The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.
The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...
Compound versions of some weight loss drugs to be restricted
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to ...
Medscape3d
Physicians Welcome Testosterone Labeling Changes
Products must note that they can increase blood pressure, but boxed warnings about adverse cardiovascular events can be ...
Zacks Investment Research on MSN3d
Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority Review
Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for ...
BioSpace11dOpinion
Opinion: FDA Faces Challenging Decision on Biomarker-Based Label Restrictions
The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo ...
Fierce Pharma20h
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...
Yahoo Finance10d
Lipocine Announces FDA Labeling Changes for Testosterone Products
The FDA is also requiring all labels to include product-specific information ... to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for ...
Managed Healthcare Executive19h
FDA Approves Novartis’ Oral Fabhalta as First Treatment for C3G.
The FDA on Thursday approved Fabhalta (iptacopan) to treat complement 3 glomerulopathy (CG3), a progressive, ultrarare kidney ...
Health Affairs22h
Fosamax Lawsuit: The Importance Of State Duties To Warn Of Drug Dangers
Fosamax further defines the obligation of drug manufacturers to present clear, unambiguous, and accurate information to the ...