FDA grants priority review for potential bronchiectasis treatment
BRIDGEWATER, N.J. - Insmed Incorporated (NASDAQ:INSM), a biopharmaceutical company with a market capitalization of $14.57 ...
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Insmed's NDA for Lung Disease Drug Gets FDA's Priority Review
Insmed Incorporated INSM announced that the FDA has accepted its new drug application (“NDA”) seeking approval of its ...
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Researchers stress need for clear, consistent standards in FDA review of psychiatric drugs
The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...
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FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
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Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
Insmed Gets Speedy FDA Review of Brensocatib for Bronchiectasis
The Bridgewater, N.J., biopharmaceutical company said brensocatib has the potential to become the first and only approved treatment for non-cystic fibrosis bronchiectasis, which causes the lungs' ...
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Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
FDA approves first new type of pain medication in 25 years
A new pain relief drug, suzetrigine, is a prescription pill that’s taken every 12 hours after a larger starter dose. It will ...
Eton Pharmaceuticals: FDA Extends ET-400 Review to Late May
Eton Pharmaceuticals said the Food and Drug Administration has extended by three months its review of the company's application seeking approval of its ET-400 liquid formulation of hydrocortisone.
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Nasal Spray Formulation of Bumetanide Under FDA Review
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
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Alvotech: FDA To Review BLA For AVT05 - Quick Facts
(RTTNews) - Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the FDA has accepted for review Biologics License Applications ...