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FiercePharma
12 小时
Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star ...
“Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective ...
BioSpace
13 小时
Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which ...
Agri-Pulse
21 小时
FDA, state feed officials seek new way to regulate ingredients
A Memorandum of Understanding between FDA and the Association of American Feed Control Officials, a group that represents ...
The American Journal of Managed Care
12 天
FDA Approves Imuldosa, a Fifth Biosimilar to Stelara
Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.
The Cincinnati Herald
11 小时
Buyer beware: Off-brand Ozempic, Zepbound and other weight loss products carry undisclosed ...
The sellers of these online products acknowledge that many of their drugs are for ‘research purposes only’ or ‘not for human ...
FiercePharma
12 天
Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months
Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pf | For the second time in six months, the FDA ...
centerforbiosimilars
12 天
FDA Approves Imuldosa, a Biosimilar to Stelara
Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.
1 天
Boston Scientific’s Strategic Expansion into the Electrophysiology Market with New FDA ...
Wells Fargo analyst Larry Biegelsen maintained a Buy rating on Boston Scientific (BSX – Research Report) yesterday and set a price target ...
centerforbiosimilars
2 天
BioRationality: Developer-Led Biosimilar Education Unnecessary, FDA’s Got It Covered
Sarfaraz K. Niazi, PhD, provides an overview of the current biosimilar education material offered by the FDA, emphasizing ...
Business Wire
8 天
FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung ...
Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) has approved Optune Lua® for ...
Politico
26 天
A compounding dilemma
THE FUTURE OF BESPOKE WEIGHT-LOSS PRODUCTS — The shortage of popular diabetes and weight-loss drugs known as GLP-1s — and insurers’ uneven coverage of them — is putting an unprecedented ...
Fresh Fruit Portal
12 天
FDA approves new non-browning Arctic Gala
The Arctic Gala joins OSF's previously approved varieties, which include Arctic Golden, Arctic Granny, and Arctic Fuji. T ...
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