Medscape2d
Physicians Welcome Testosterone Labeling Changes
Products must note that they can increase blood pressure, but boxed warnings about adverse cardiovascular events can be ...
Lipocine Announces FDA Labeling Changes for Testosterone Products
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and ...
US FDA issues labeling changes for testosterone products
The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products based on ...
JD Supra7d
FDA Guidance for Labeling Plant-based Products
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...
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 ...
Fierce Pharma3d
Dr. Reddy’s, Sun Pharma and Zydus issue US recalls, citing failed specs and labeling issues
The companies in question, Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, are recalling seizure treatments, ...
Novartis1h
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...
Business Insider8d
Lipocine announces FDA labeling changes for testosterone products
Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This decision follows the Agency’s review of the ...
Finanznachrichten8d
Lipocine Inc.: Lipocine Announces FDA Labeling Changes for Testosterone Products
The FDA is also requiring all labels to include product-specific information on increased blood pressure for testosterone products based on the results of ABPM studies. "We are excited about these ...