FDA approves first drug to target a genetic cause of ALS – it’s from Biogen
The U.S Food and Drug Administration approved Biogen’s ALS drug QALSODY Tuesday afternoon.
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FDA approval
Mycovia Pharmaceuticals submits New Drug Application for oteseconazole
After three clinical trials, Mycovia has submitted its New Drug Application for a therapy that could help patients with recurrent vulvovaginal candidiasis, chronic yeast infection.
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Istari Oncology, now with FDA clearance for PVSRIPO, raises $43.4M
Istari Oncology received FDA clearance to move forward on a Phase 1/2 clinical trial to test a drug treatment that may help treat patients with cancer.
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United Therapeutics submits new drug application to FDA to treat pulmonary arterial hypertension
United Therapeutics has filed a new drug application to the U.S. FDA, and asked for priority review.
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Glenmark Pharmaceuticals gets FDA approval to market NC-made drug
Glenmark Pharmaceuticals has received FDA approval to market its NC-made anti-malaria drug in the US.
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MED-EL USA gets FDA clearance for ADHEAR
DURHAM – MED-EL USA, which develops and sells hearing implant solutions, has received clearance from the U.S. Food and Drug Administration for its non-surgical bone conduction hearing technology, ADHEAR. The Austrian company has US headquarters in Durham.
Read MoreFDA approved Aerie Pharmaceuticals drug offers new glaucoma treatment
Aerie Pharmaceuticals, a California-based Duke University spinoff that has research and development operations in the Triangle, has received US Food and Drug administration approval for its glaucoma drug delivered once a day via eyedrops.
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