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Ascendis Hypoparathyroidism Drug Approved

[ Price : $8.95]

FDA approves an Ascendis Pharma NDA for Yorvipath (palopegteriparatide) for treating hypoparathyroidism in adults.

FDA Needs More Time on Humacyte BLA Review

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FDA tells Humacyte it needs more time to complete the review of BLA for the acellular tissue-engineered vessel, indicated for trea...

FDA OKs Neffy Allergic Reaction Nasal Spray

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FDA approves an ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions.

Braun Recalls 2 Sodium Chloride Lots

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Braun Medical recalls (Class 1) two lots of 0.9% sodium chloride for injection USP 1,000 mL due to the potential for particulate m...

Cardiologist to Lead Digital Health Panel

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FDA selects American College of Cardiology chief innovation officer Ami Bhatt to serve a four-year term as chair of the agencys re...

Guide on Oncologic Drug Dose Optimization

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Federal Register notice: FDA makes available a final guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biolo...

Guide BCG-Unresponsive Bladder Cancer Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Bacillus Calmette-Gurin-Unresponsive Nonmuscle Invasive Bla...

Hold Lifted on Fabry Cardiomyopathy Therapy

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FDA lifts a clinical hold against 4D Molecular Therapeutics 4D-310 therapy being studied for treating Fabry disease cardiomyopathy...

Panel to Mull Clozapine REMS Potential Changes

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Federal Register notice: FDA announces an 11/19 advisory committee meeting to discuss potential changes to the clozapine risk eval...

4 Observations on Imprimis FDA-483

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FDA releases the form FDA-483 with four observations from an inspection at the Ledgewood, NJ-based Imprimis NJOF outsourcing facil...