Food and Drug Administration, Novo Nordisk

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad
With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency "reminds compounders of the legal restrictions on making copies of FDA-approved drugs."
Novo Nordisk asks US to stop compounding pharmacies from making weight-loss drug copies
Novo Nordisk on Tuesday asked the U.S. Food and Drug Administration to ban compounding pharmacies from making copycat versions of its popular weight-loss and diabetes drugs, which it said were too complex for those manufacturers to produce safely.
Ozempic maker Novo Nordisk wants the FDA to crack down on knockoff weight loss drugs
Ozempic maker Novo Nordisk (NVO) is asking the U.S. Food and Drug Administration (FDA) to prohibit compounding pharmacies from making off-brand versions of semaglutide, the active ingredient in its blockbuster weight loss and diabetes medications.
Novo Nordisk asks FDA to block compounding pharmacies from making Ozempic copy-cats
Novo Nordisk wants the Food and Drug Administration (FDA) to prevent compounding pharmacies from manufacturing their own versions of the company’s popular weight loss drug Wegovy and diabetes
The Maker of Ozempic Is Trying to Block Compounded Versions of Its Blockbuster Drug
Novo Nordisk has asked the FDA to block production of compounded copies of Ozempic, arguing that it’s too difficult to do safely. It’s the latest escalation in a brewing war between pharmaceutical companies and compounders.
Novo Nordisk asks FDA to ban compounding pharmacies from making Ozempic, Wegovy copies
The Danish drugmaker Novo Nordisk argues that semaglutide, the active ingredient in Ozempic and Wegovy, are too complex for those manufacturers to make safely.
Novo asks FDA to bar compounders from making Ozempic copies
The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable Difficulties for Compounding Lists."
PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application
PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a ...
Food Safety News5d
FDA updates food import alerts for unapproved drugs, heavy metals and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.
Recent recalls raise concerns about food safety, but experts credit better regulation and technology
According to FDA data, nearly 1,200 food products have been recalled so far in 2024. Two hundred products were recalled in ...
McDonald's president expresses confidence in food safety after outbreak and death
The popular fast-food restaurant wants customers to feel "confident" ordering from its restaurants after an E. coli outbreak ...
STAT15d
Q&A: How the FDA is approaching AI in clinical trials and drug development
The FDA's Tala Fakhouri discusses the agency's approach to the regulation of AI in clinical trials in a new interview.
Food and Drug Administration "Blocking Overseas Direct Purchase of Obesity Treatment"...Setting the forbidden word for Hugo Bee and Saxenda
The Ministry of Food and Drug Safety said it will block the entry of the recently released GLP-1 obesity treatment "Wigobi" ...
Business Wire26d
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s COBENFY™ (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of ...
today announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.
Austin American-Statesman24d
FDA issues recalls on at least 16 food and drug items in September. Here's a list
This could be due to U.S. Food and Drug Administration recalls. The FDA has continued to suspend food and drug items that people might typically buy. Here is a list of September food and ...
Kellogg is under fire for using artificial food dyes. Here’s how they may affect your health and where else to find them
Kellogg had pledged back in 2015 to remove artificial dyes from its foods by 2018. But that hasn’t happened, despite the ...
Telix Pharmaceuticals Limited: FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara) Brain Cancer Imaging Agent
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has ...
SCOTUSblog22d
Food and Drug Administration v. R.J. Reynolds Vapor Co.
Issue: Whether a manufacturer may file a petition for review in a circuit (other than the U.S. Court of Appeals for the District of Columbia Circuit) where it neither resides nor has its principal ...
Amid McDonald’s-linked E. coli outbreak, here are symptoms to watch for and ways to stay safe
An outbreak of infections linked to McDonald’s Quarter Pounders has a lot of people across the United States concerned about ...