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Medical Devices

Magnus Medical Neurostimulation for Depression Cleared

FDA clears a Magnus Medical 510(k) for the Saint Neuromodulation System for treating major depressive disorder in adults who have failed to achieve sa...

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Human Drugs

FDA Approves Fresenius Kabi Biosimilar

FDA approves Fresenius Kabis Stimufend biosimilar for Amgens Neulasta.

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Human Drugs

Data Not Conclusive on Amylyx ALS Drug: FDA

FDA reviewers dismiss new analyses and data from Amylyx that were intended to provide confirmatory evidence to support approval of its amyotrophic lat...

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Federal Register

BioMarin Wins Priority Review Voucher

Federal Register notice: FDA announces the issuance of a priority review voucher to BioMarin Pharmaceutical for a rare pediatric disease product appli...

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Human Drugs

FDA Approves Boehringer Pustular Psoriasis Drug

FDA approves a Boehringer Ingelheim NDA for Spevigo (spesolimab) as a treatment option for generalized pustular psoriasis flares in adults.

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Federal Register

Panel to Review Glaxo Kidney Disease Anemia Drug

Federal Register notice: FDA advisory committee reviews GlaxoSmithKline NDA for daprodustat, indicated for treating anemia due to chronic kidney disea...

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Human Drugs

Azurity's Konvomep Approved for Gastric Ulcers

FDA approves an Azurity Pharmaceuticals NDA for Konvomep (omeprazole and sodium bicarbonate for oral suspension), a proton pump inhibitor for treating...

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Medical Devices

Vibrant Gastro Colon Vibrator Gets Authorization

FDA grants Vibrant Gastro de novo marketing authorization for its Vibrant, an orally administered drug-free capsule that provides mechanical stimulati...

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Human Drugs

Imfinzi Approved for Biliary Tract Cancer

FDA approves an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for combination use with gemcitabine and cisplatin for adult patients with local...

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Federal Register

AstraZeneca Asthma Drug Goes Before Panel

Federal Register notice: FDA announces an 11/8 Pulmonary-Allergy Drugs Advisory Committee meeting to review AstraZeneca NDA for a combination metered ...