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Makary Says Vaccine Framework Coming Soon

[ Price : $8.95]

FDA commissioner Marty Makary says the agency is planning to release in the coming days a vaccine development framework to help wi...

Amneals Brekiya Approved for Migraines

[ Price : $8.95]

FDA approves Amneals Brekiya, the only dihydrogotamine mesylate autoinjector available to treat migraine and cluster headaches in ...

FDA Accepts BioCryst Orladeyo NDA

[ Price : $8.95]

FDA accepts a BioCryst NDA for Orladeyo to be used in pediatric patients with hereditary angioedema.

Positive Data on Keytruda in Ovarian Cancer: Merck

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Merck's Keytruda meets a Phase 3 clinical trial primary endpoint of progression-free survival for treating patients with platinum-...

FDA OKs Incytes Zynyz for Anal Cancer

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FDA approves an Incyte supplemental BLA for Zynyz (retifanlimab-dlwr) in combination with carboplatin and paclitaxel for the first...

CGMP Violations at Chinas Shantou S.E.Z. Baojie

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FDA warns Chinas Shantou S.E.Z. Baojie Industry about CGMP violations in its production of finished drugs, some of which may be re...

FDA Doubts May Move Trials Overseas: Report

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Biotech executives, investors, and consultants say some companies are moving early clinical trials overseas due to fears of instab...

FDA OKs First Oral Therapy for Rare Adrenal Tumors

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FDA approves a Merck NDA for Welireg (belzutifan), an oral drug for treating adults and pediatric patients aged 12 and older with ...

AbbVies Emrelis Approved for Lung Cancer

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FDA gives AbbVie accelerated approval for its Emrelis (telisotuzumab vedotin-tllv) for treating certain adult patients with locall...

BrightHeart AI Fetal Heart Ultrasound Checker Cleared

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FDA clears a BrightHeart 510(k) for the B-Right Views, an artificial intelligence-powered tool that automatically detects the stan...