Supernus Pharmaceuticals, Inc. announced that the FDA has approved an updated label for Qelbree (viloxazine extended-release capsules) to include new pharmacodynamic data, highlighting its serotonin 5 ...
Alnylam Pharmaceuticals, Inc. ALNY recently announced that the FDA has approved its RNAi therapeutic administered via subcutaneous injection, Oxlumo (lumasiran) for a new indication. The injection is ...
The Skinny Labels, Big Savings Act was introduced on January 9 in an effort to provide “a statutory safe harbor from patent ...
Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates for its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) ...
Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval for Uplizna, now approved as a treatment for immunoglobulin G4-related ...
PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update ...
The U.S. Food Safety and Inspection Service (FSIS) recently issued a final rule expanding the circumstances under which it will generically approve the labels of meat, poultry, and egg products. As a ...
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