The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
FDA clears United Therapeutics for human trials of pig-to-human kidney transplants. Trial involves gene-edited pig kidneys ...
Magdalena aiming to submit Investigational New Drug (IND) application in 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ...
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...
Celltrion launches ADC cancer drug trials in U.S. while planning additional INDs Celltrion accelerates its global drug ...
BRIDGEWATER, N.J. - Insmed Incorporated (NASDAQ:INSM), a biopharmaceutical company with a market capitalization of $14.57 ...
The FDA will review a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).
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