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Novel Drug Approvals for 2026
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CRITICAL95
APPROVAL · PRIMARY SOURCE

Novel Drug Approvals for 2026

The FDA approved Foundayo (orforglipron), a GLP-1-type peptide drug, on April 1, 2026, to help adults with obesity or overweight lose weight and keep it off when used with diet and exercise. The agency also cleared Awiqli (insulin icodec-abae), a long-acting insulin peptide, for blood sugar control in type 2 diabetes on March 26, 2026.

Analysis

Lilly's Foundayo (orforglipron) becomes the first oral GLP-1 approved for obesity, opening a pill-based weight-loss market and pressuring injectable franchises on convenience.

  • FDA approved Foundayo (orforglipron) on 4/1/2026 for obesity/overweight with comorbidity
  • Indication requires combination with reduced-calorie diet and increased physical activity
  • FDA also cleared Awiqli (insulin icodec-abae) on 3/26/2026 for type 2 diabetes glycemic control
FDA Drug Approvals & Databases2d
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BREAKING
MAJOR88
COMMERCIALLimited grounding

Trump says U.S. to provide GLP-1 drugs for Medicare patients - Reuters

President Trump announced that the U.S. government will provide GLP-1 drugs (weight-loss and diabetes medications) to Medicare patients. The statement signals potential government coverage expansion for these expensive medications.

Analysis

Medicare coverage of GLP-1s would unlock the largest untapped payer pool for Lilly and Novo, materially expanding the addressable obesity market.

  • Trump said the U.S. will provide GLP-1 drugs to Medicare patients
  • Announcement signals potential federal coverage expansion for GLP-1s
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Lilly posts another ‘blowout quarter’ as focus turns to Foundayo launch
BREAKING
MAJOR88
COMMERCIAL

Lilly posts another ‘blowout quarter’ as focus turns to Foundayo launch

Eli Lilly reported record earnings in the first quarter of 2026, driven by strong overseas sales of Mounjaro (a GLP-1 diabetes and weight-loss drug). The company is now focused on launching Foundayo, its new pill form of the drug, which the FDA approved in April, and says 80% of early prescriptions are going to patients trying GLP-1 drugs for the first time.

Analysis

Lilly's 60% US GLP-1 share and Mounjaro's $8.7B quarter cement dominance over Novo, while Foundayo's 80% new-to-class uptake suggests pill expands rather than cannibalizes the market.

  • Q1 2026 revenue rose 56% to $19.8B, beating estimates by $2B+
  • Mounjaro/Zepbound sales more than doubled to $8.7B
  • Lilly holds 60%+ US GLP-1 share vs Novo's 39.4%
BioPharma Dive3d
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BREAKING
MAJOR88
REGULATORYLimited grounding

FDA proposes excluding Novo, Lilly weight loss drugs from bulk compounding list in win for the companies - CNBC

The FDA is proposing to remove weight-loss drugs made by Novo Nordisk and Eli Lilly from a list of medicines that pharmacies can copy and make in bulk. This would be good for the companies because it would force more patients to buy their brand-name versions instead of cheaper pharmacy-made copies.

Analysis

FDA move to bar bulk compounding of Novo and Lilly GLP-1s removes the cheap-copy workaround, redirecting demand back to branded Wegovy, Ozempic, Zepbound and Mounjaro.

  • FDA proposes excluding Novo and Lilly weight-loss drugs from bulk compounding list
  • Move would restrict pharmacies from making bulk copies of the drugs
  • Patients would be pushed toward brand-name versions
Tirzepatide News3d
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MAJOR88
APPROVALLimited grounding

Health Canada approves 1st generic version of Novo Nordisk's Ozempic - CBC

Health Canada approved the first generic version of semaglutide (Ozempic), Novo Nordisk's popular diabetes and weight-loss drug. This means Canadian patients may soon have access to a cheaper alternative to the brand-name version.

Analysis

First semaglutide generic clearance in a major market cracks Novo's Ozempic monopoly earlier than expected, foreshadowing global pricing pressure as patent cliffs approach.

  • Health Canada approved the first generic version of Ozempic (semaglutide).
  • Approval covers Novo Nordisk's diabetes and weight-loss drug.
  • Canadian patients may gain access to a cheaper alternative to the brand.
Novo Nordisk News5d
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BREAKING
MAJOR88
CLINICAL TRIALLimited grounding

Boehringer-Zealand drug leads to 16.6% weight loss in late-stage trial - Reuters

A drug made by Boehringer Ingelheim and Zealand Pharma helped people lose 16.6% of their body weight in a late-stage trial (a big test before the FDA decides whether to approve a medicine). This is positive news for the companies' weight-loss drug program.

Analysis

Survodutide's 16.6% weight loss puts Boehringer-Zealand in striking range of incumbent GLP-1s, adding a credible third entrant to the obesity market dominated by Lilly and Novo.

  • Boehringer-Zealand drug delivered 16.6% weight loss in late-stage trial
  • Trial is Phase 3 (pre-FDA decision stage)
Reuters Health5d
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BREAKING
MAJOR88
CLINICAL TRIALLimited grounding

Zealand Pharma announces Boehringer Ingelheim's novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people with obesity or overweight in Phase 3 trial - BioSpace

Boehringer Ingelheim's survodutide, a dual-action drug that targets two hormones (glucagon and GLP-1) to help with weight loss, showed people lost an average of 16.6% of their body weight in a late-stage trial. The drug also improved other measures of metabolic health in people with obesity or excess weight.

Analysis

Survodutide's 16.6% weight loss puts Boehringer/Zealand's glucagon/GLP-1 dual agonist in striking range of tirzepatide, adding a credible third entrant to the obesity drug race.

  • Survodutide delivered 16.6% weight loss in Phase 3 obesity trial
  • Drug is a glucagon/GLP-1 dual agonist from Boehringer Ingelheim, partnered with Zealand
  • Trial showed metabolic improvements in people with obesity or overweight
BioSpace5d
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BREAKING
MAJOR88
CLINICAL TRIALLimited grounding

Eli Lilly's next-generation obesity drug secures first phase III win - MSN

Eli Lilly's retatrutide, a next-generation weight-loss drug, has passed its first major late-stage trial (Phase 3 trial), which tests whether a drug actually works in patients. This is an important step toward getting the drug approved by regulators.

Analysis

Retatrutide's first Phase 3 win advances Lilly's triple-agonist toward approval, threatening Novo's GLP-1 franchise with a potentially best-in-class obesity drug.

  • Retatrutide passed its first Phase 3 trial
  • Drug is positioned as Lilly's next-generation obesity therapy
  • Result advances retatrutide toward regulatory submission
Retatrutide News6d
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BREAKING
MAJOR86
COMMERCIALLimited grounding

Novo Nordisk to cut US list prices for Ozempic, Wegovy by up to 50% - MSN

Novo Nordisk is lowering the advertised U.S. prices for Ozempic (a diabetes drug) and Wegovy (a weight-loss drug) by as much as 50%. This is the company's move to make these expensive medications more affordable for patients and insurers.

Analysis

Novo's up-to-50% list price cut on Ozempic and Wegovy resets US GLP-1 pricing benchmarks and pressures Lilly to follow on tirzepatide.

  • Novo Nordisk to cut US list prices for Ozempic and Wegovy by up to 50%
  • Move targets affordability for patients and insurers
Novo Nordisk News1d
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BREAKING
MAJOR86
CLINICAL TRIALLimited grounding

Boehringer Ingelheim’s novel glucagon/GLP-1 dual agonist survodutide achieved significant weight loss of 16.6% delivering meaningful metabolic improvement in people with obesity or overweight in Phase III trial - Boehringer Ingelheim

Boehringer Ingelheim announced that survodutide, a dual-action drug that works like both glucagon and GLP-1 (weight-loss hormones), helped people lose 16.6% of their body weight in a Phase III trial (a large late-stage test). The drug also improved other health markers related to metabolism in people with obesity or excess weight.

Analysis

Survodutide's 16.6% weight loss puts Boehringer/Zealand's glucagon-GLP-1 dual agonist into competitive range with tirzepatide, validating the dual-agonist mechanism beyond Lilly.

  • Survodutide hit 16.6% weight loss in Phase III obesity trial
  • Drug is a glucagon/GLP-1 dual agonist from Boehringer Ingelheim
  • Trial showed metabolic improvements in obesity/overweight patients
Retatrutide News5d
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BREAKING
MAJOR82
APPROVALLimited grounding

Apotex becomes the first Canadian‑based pharmaceutical company to receive Health Canada approval for a generic equivalent of Ozempic® - PR Newswire

Apotex, a Canadian drugmaker, got approval from Health Canada to sell a generic copy of Ozempic (semaglutide), a popular weight-loss and diabetes medicine. This is the first generic version approved by Canada's health regulator.

Analysis

First Health Canada generic semaglutide approval breaches Novo's Ozempic franchise in a major market, foreshadowing global IP erosion as semaglutide patents face challenges.

  • Apotex received Health Canada approval for a generic equivalent of Ozempic (semaglutide)
  • First Canadian-based pharma company to win generic Ozempic approval in Canada
Semaglutide News2d
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Lilly reports first-quarter 2026 financial results, raises full year guidance, and highlights momentum of new medicines
BREAKING
MAJOR82
COMMERCIAL · PRIMARY SOURCELimited grounding

Lilly reports first-quarter 2026 financial results, raises full year guidance, and highlights momentum of new medicines

Eli Lilly reported strong first-quarter 2026 earnings, with total revenue jumping 56% to $19.8 billion, driven largely by higher sales volume of its diabetes and weight-loss drugs Mounjaro and Zepbound. However, the company earned less money per dose sold due to lower prices for those two medicines.

Analysis

Lilly's 56% revenue surge confirms Mounjaro/Zepbound demand remains the dominant growth engine in obesity, though price erosion per dose flags margin pressure as competition intensifies.

  • Q1 2026 total revenue rose 56% to $19.8 billion
  • Growth driven by higher Mounjaro and Zepbound sales volume
  • Realized price per dose declined for both drugs
Eli Lilly Press Releases3d
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BREAKING
MAJOR82
APPROVALLimited grounding

Canada Approves Dr. Reddy’s Generic Version of Novo Nordisk’s Ozempic - WSJ

Canada approved a generic version of semaglutide (the active ingredient in Ozempic) made by Dr. Reddy's Laboratories. This generic copy is cheaper and could give more people access to the weight-loss and diabetes drug.

Analysis

First generic semaglutide approval in a major market signals the start of Novo's loss-of-exclusivity erosion, with Dr. Reddy's positioned to undercut Ozempic on price.

  • Canada approved Dr. Reddy's generic version of semaglutide
  • Semaglutide is the active ingredient in Novo Nordisk's Ozempic
  • Generic is cheaper and aims to broaden access for diabetes and weight loss
Novo Nordisk News4d
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BREAKING
MAJOR82
APPROVALLimited grounding

Dr. Reddy's Laboratories Announces Health Canada Approval for Generic Semaglutide Injection in Canada - Business Wire

Dr. Reddy's Laboratories received approval from Health Canada to sell a generic version of semaglutide injection in Canada. This is the first generic copy of the popular weight-loss and diabetes drug to be approved there.

Analysis

First generic semaglutide cleared in Canada erodes Novo Nordisk's Ozempic/Wegovy moat ahead of broader patent cliffs, signaling accelerating biosimilar/generic pressure on GLP-1 franchises.

  • Dr. Reddy's received Health Canada approval for generic semaglutide injection
  • First generic semaglutide approved in Canada
  • Approval covers weight-loss and diabetes indications
Semaglutide News4d
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BREAKING
MAJOR82
APPROVALLimited grounding

Canada approves first generic version of Ozempic amid rising GLP-1 competition - Reuters

Canada's health authority approved the first generic copy of semaglutide (Ozempic), the popular weight-loss and diabetes drug. This approval means cheaper versions of the medicine may become available as more companies compete to make GLP-1 drugs.

Analysis

First generic semaglutide approval in Canada cracks Novo Nordisk's Ozempic monopoly in a major market, foreshadowing global pricing pressure as more GLP-1 generics queue up.

  • Canada approved the first generic version of semaglutide (Ozempic)
  • Approval opens the door to cheaper GLP-1 alternatives in Canada
  • Decision arrives amid rising competition in the GLP-1 class
Reuters Health5d
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BREAKING
MAJOR82
CLINICAL TRIALLimited grounding

Boehringer links dual agonist to 16.6% weight loss in phase 3, but leaves key questions unanswered - Fierce Biotech

Analysis

Survodutide's 16.6% phase 3 weight loss puts Boehringer/Zealand's GLP-1/glucagon dual agonist in striking range of tirzepatide and semaglutide, validating the dual-agonist class.

  • Boehringer's dual agonist hit 16.6% weight loss in phase 3
  • Phase 3 readout leaves key questions unanswered
FierceBiotech5d
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BREAKING
MAJOR78
APPROVALLimited grounding

Generic version of Ozempic approved in Canada: What you need to know - MSN

Canada approved a generic version of semaglutide, the active ingredient in Ozempic. This means Canadian patients may have access to a cheaper alternative to the brand-name weight-loss and diabetes drug.

Analysis

Canadian generic semaglutide approval opens the first major market crack in Novo Nordisk's Ozempic franchise, foreshadowing pricing pressure as global patent cliffs approach.

  • Canada approved a generic version of semaglutide, the active ingredient in Ozempic.
  • Generic entry positions Canadian patients for a cheaper alternative to brand-name Ozempic.
Semaglutide News9h
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MAJOR78
APPROVALLimited grounding

Canada approves second generic version of Ozempic - Reuters

Canada's health regulator approved a second generic copy of semaglutide (Ozempic), the popular diabetes and weight-loss drug made by Novo Nordisk. More generic options could help lower costs for patients in Canada.

Analysis

Second Canadian semaglutide generic erodes Novo's Ozempic franchise ahead of broader patent cliffs, signaling accelerating generic pressure in non-US markets.

  • Canada's health regulator approved a second generic version of semaglutide (Ozempic)
  • Ozempic is made by Novo Nordisk
  • More generic options could help lower costs for patients in Canada
Reuters Health2d
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BREAKING
MAJOR78
APPROVALLimited grounding

Canada approves second generic version of Ozempic By Reuters - Investing.com

Canada's health authority approved a second generic version of semaglutide (Ozempic), the popular weight-loss and diabetes drug. More generic copies available could lower prices and help more people afford the medicine.

Analysis

Canada clearing a second semaglutide generic erodes Novo's Ozempic franchise in a key market ahead of broader patent cliffs, signaling accelerating generic pressure on GLP-1 pricing.

  • Canada approved a second generic version of semaglutide (Ozempic)
  • Additional generics expected to lower prices and broaden access
Semaglutide News2d
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BREAKING
MAJOR78
APPROVALLimited grounding

Health Canada approves 2nd generic version of Ozempic — and it's Canadian - CBC

Health Canada approved a second generic version of semaglutide (the active ingredient in Ozempic), made by a Canadian company. This gives patients another cheaper alternative to the brand-name weight-loss and diabetes drug.

Analysis

Second semaglutide generic clears Health Canada, accelerating Ozempic price erosion in Canada ahead of Novo's anticipated patent cliff in other markets.

  • Health Canada approved a second generic version of semaglutide
  • The generic is manufactured by a Canadian company
  • Ozempic is Novo Nordisk's branded semaglutide for diabetes and weight loss
Semaglutide News2d
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BREAKING
MAJOR78
APPROVALLimited grounding

Canada approves second generic version of Ozempic - Yahoo! Finance Canada

Canada approved a second generic version of Ozempic (a semaglutide injection used for diabetes and weight loss). This expands access to cheaper copies of the drug beyond Novo Nordisk's brand-name version.

Analysis

Second semaglutide generic approval in Canada accelerates branded Ozempic erosion for Novo Nordisk in a key ex-US market, signaling broader patent-cliff dynamics ahead.

  • Canada approved a second generic version of Ozempic (semaglutide injection)
  • Generic is indicated for diabetes and weight loss
  • Approval adds a second copycat competing with Novo Nordisk's brand
Novo Nordisk News2d
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BREAKING
MAJOR78
APPROVALLimited grounding

Canada Approves Second Generic Version of Ozempic - U.S. News Money

Canada has approved a second generic copy of semaglutide (the drug in Ozempic). This means more affordable versions of the popular weight-loss and diabetes medicine are becoming available to Canadian patients.

Analysis

Second semaglutide generic in Canada accelerates erosion of Novo's Ozempic franchise in a key market, foreshadowing global generic pressure as patents lapse.

  • Canada approved a second generic version of semaglutide
  • Semaglutide is the active ingredient in Novo Nordisk's Ozempic
Semaglutide News2d
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BREAKING
MAJOR78
APPROVALLimited grounding

Novo Nordisk's Ozempic® pill, the only FDA-approved oral peptide GLP-1 medication for adults with type 2 diabetes, soon to be available in the US - BioSpace

Novo Nordisk's oral form of Ozempic (a GLP-1 peptide drug for type 2 diabetes) has FDA approval and will soon be available in the United States. This is the first FDA-approved pill version of a GLP-1 peptide medication for adults with type 2 diabetes.

Analysis

First FDA-approved oral GLP-1 peptide for T2D gives Novo a differentiated delivery format versus Lilly's injectables, expanding addressable patients who resist needles.

  • FDA approved Novo Nordisk's oral Ozempic for adults with type 2 diabetes
  • Positioned as the only FDA-approved oral peptide GLP-1 for T2D
  • US launch imminent per Novo Nordisk
BioSpace2d
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BREAKING
MAJOR78
APPROVALLimited grounding

Novo Nordisk's Ozempic® pill, the only FDA-approved oral peptide GLP-1 medication for adults with type 2 diabetes, soon to be available in the US - PR Newswire

Novo Nordisk's oral version of Ozempic (a GLP-1 peptide drug used for type 2 diabetes) will become available in the United States soon. This is the only FDA-approved pill form of this type of medication for adults with diabetes.

Analysis

Oral Ozempic launch gives Novo a differentiated pill-form GLP-1 in T2D, pressuring Lilly's injectable franchise and pre-empting oral entrants like orforglipron and danuglipron.

  • Novo Nordisk's oral Ozempic to become available in the US soon
  • Only FDA-approved oral peptide GLP-1 for adults with type 2 diabetes
Novo Nordisk News2d
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BREAKING
MAJOR78
REGULATORYLimited grounding

Eli Lilly, Novo Nordisk Stocks Jump as FDA Moves Against Bulk Production of Obesity Drug Ingredients - TipRanks

The FDA is taking action against bulk production of obesity drug ingredients, which helped stock prices rise for Eli Lilly and Novo Nordisk. This move could benefit the companies by reducing competition from cheaper, bulk-made versions of weight-loss medicines.

Analysis

FDA action against bulk obesity drug ingredient production removes a key supply line for compounders, reinforcing Lilly and Novo's branded GLP-1 pricing power.

  • FDA moving against bulk production of obesity drug ingredients
  • Eli Lilly and Novo Nordisk shares rose on the news
Obesity Drug FDA News3d
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BREAKING
MAJOR78
CLINICAL TRIALLimited grounding

Boehringer’s GLP-1 dual agonist survodutide shines in phase III trial - European Pharmaceutical Review

Boehringer Ingelheim's survodutide, a GLP-1 dual agonist (a type of weight-loss and diabetes drug), showed positive results in a large Phase 3 trial (a major test required before FDA approval). The company is advancing the drug toward regulatory approval based on these successful trial results.

Analysis

Positive Phase 3 for survodutide validates the GLP-1/glucagon dual-agonist class and strengthens Boehringer/Zealand's position against Lilly and Novo in obesity.

  • Boehringer Ingelheim's survodutide hit positive results in a Phase 3 trial
  • Survodutide is a GLP-1/glucagon dual agonist for weight loss and diabetes
  • Company advancing the drug toward regulatory approval
Retatrutide News4d
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BREAKING
MAJOR78
APPROVALLimited grounding

Dr Reddy's Wins Nod to Sell Generic Ozempic, Check Cost Of Weight-Loss Drug - NDTV

Dr. Reddy's has received approval to sell a generic version of semaglutide (Ozempic), a popular weight-loss and diabetes drug. The article indicates pricing information for this generic option will be available, potentially offering a lower-cost alternative to the brand-name version.

Analysis

Generic semaglutide entry from Dr Reddy's threatens Novo Nordisk's Ozempic franchise in markets where patent protection has lapsed, accelerating pricing pressure on the GLP-1 leader.

  • Dr Reddy's received approval to sell a generic version of semaglutide (Ozempic)
  • Generic launch positioned as lower-cost alternative to brand-name Ozempic
Semaglutide News4d
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BREAKING
MAJOR78
CLINICAL TRIALLimited grounding

Dual-Agonist Survodutide Shows Significant Weight Loss in Phase III Obesity Trial - BioPharm International

Survodutide, a drug that works on two different body signals to reduce weight, showed strong results in a Phase 3 trial (a large test needed before the FDA considers approval). The trial tested whether survodutide could help people with obesity lose weight.

Analysis

Survodutide Phase 3 obesity readout positions Zealand/Boehringer's GLP-1/glucagon dual agonist as a credible challenger to tirzepatide and semaglutide in the weight-loss class.

  • Survodutide met endpoints in a Phase 3 obesity trial
  • Drug is a dual agonist mechanism
  • Trial tested weight loss in patients with obesity
Retatrutide News5d
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BREAKING
MAJOR72
APPROVALLimited grounding

Dr. Reddy’s Laboratories Gains Health Canada Approval for Generic Semaglutide Injection in 2 mg and 4 mg Pens - geneonline.com

Dr. Reddy's Laboratories received approval from Health Canada (the Canadian health regulator) to sell a generic version of semaglutide injection in 2 mg and 4 mg pen formats. This approval means Canadians will have access to a cheaper copy of this popular weight-loss and diabetes drug.

Analysis

Dr. Reddy's lands one of the first Health Canada nods for generic semaglutide, opening a non-US pressure point on Novo Nordisk's Ozempic/Wegovy franchise ahead of broader patent cliffs.

  • Health Canada approved Dr. Reddy's generic semaglutide injection
  • Approval covers 2 mg and 4 mg pen formats
Semaglutide News13h
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