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FDA Approves Fresenius Kabi Biosimilar

[ Price : $8.95]

FDA approves Fresenius Kabis Stimufend biosimilar for Amgens Neulasta.

Data Not Conclusive on Amylyx ALS Drug: FDA

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

AstraZeneca Asthma Drug Goes Before Panel

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

BioMarin Wins Priority Review Voucher

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

FDA Approves Boehringer Pustular Psoriasis Drug

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

Panel to Review Glaxo Kidney Disease Anemia Drug

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

Azurity's Konvomep Approved for Gastric Ulcers

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

Vibrant Gastro Colon Vibrator Gets Authorization

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

Imfinzi Approved for Biliary Tract Cancer

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

Integra CereLink Monitor Recall is Class 1

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FDA says the Integra recall of 388 CereLink intracranial pressure monitors is Class 1.