The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation (RPDD) to Arbor Biotechnologies' gene editing therapeutic, ABO-101, to treat ...

The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...

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 ...

BRIDGEWATER, N.J. - Insmed Incorporated (NASDAQ:INSM), a biopharmaceutical company with a market capitalization of $14.57 ...

On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...

NEW YORK, NY / ACCESS Newswire / February 5, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want ...

The FDA approved an apomorphine hydrochloride infusion device (Onapgo) to treat motor fluctuations in adults with advanced ...

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...

The fallout from the F.D.A.’s rejection of MDMA-assisted treatment for PTSD worries researchers and experts who fear other ...

The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...

Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food ...