The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...
Fosamax further defines the obligation of drug manufacturers to present clear, unambiguous, and accurate information to the ...
Zacks Investment Research on MSN1d
Alnylam Gets FDA Nod for Expanded Use of Amvuttra in CardiomyopathyAlnylam Pharmaceuticals ALNY announced that the FDA had approved its regulatory filing seeking the label expansion of its ...
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to ...
Products must note that they can increase blood pressure, but boxed warnings about adverse cardiovascular events can be ...
This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with ...
The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo ...
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Bayer's sNDA for Kerendia Label Expansion Gets FDA's Priority ReviewBayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for ...
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 ...
Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...
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