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FDA grants orphan drug status to Arbor Biotechnologies’ PH1
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 ...
verywellhealth3h
A New 'Missile' Drug Is Approved To Treat the Most Common Breast Cancer Type
The FDA approved Datroway to treat metastatic or unresectable HR+/HER2- breast cancer in people who have tried standard chemo ...
Updated drug information handout outdoes FDA's version in clinical trial
A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an ...
Magdalena Biosciences, a Joint Venture Between Jaguar Health and Filament Health, to Present February 10th at BIO CEO & Investor Conference
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 ...
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 ...
Targeted Oncology11h
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 ...