Beren Therapeutics Announces FDA Extension of Review Period for New Drug Application (NDA) for Adrabetadex for the Treatment of Infantile-Onset Niemann-Pick Disease, Type C

Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and a leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, announced that the U.S. Food and Drug Administration ...
The Pharma Letter

FDA extends review timeline of Beren’s adrabetadex NDA

Beren Therapeutics announced that the US Food and Drug Administration (FDA) has extended by three months the review timeline of its New Drug Application (NDA) for adrabetadex for the treatment of ...
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BAYRY's Kerendia Label Expansion Application Gets Priority Review

Bayer AG BAYRY announced that the FDA has accepted the company’s supplemental new drug application (sNDA) seeking label ...

Nuvation Bio Inc.: Nuvation Bio Announces FDA Acceptance of Supplemental New Drug Application for IBTROZI (taletrectinib) with Updated Duration of Response in Advanced ROS1 ...

Application includes updated TRUST-I TKI-naïve median duration of response (mDOR) and median progression-free survival (mPFS) of more than 4 years, as well as TRUST-II ...
MarketBeat on MSN

Compass Pathways eyes Q4 FDA filing for psilocybin depression drug after phase 3 wins

Key Points Interested in Compass Pathways PLC Sponsored ADR? Here are five stocks we like better. Compass Pathways said it ...