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5 Items in Dr. Reddys Form FDA-483

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FDA issues Dr. Reddy's Laboratories a five-item Form FDA-483 after inspecting the firms drug substance and drug product manufactur...

Datroway Positive Data in Breast Cancer Patients

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AstraZeneca and Daiichi Sankyo report new data showing that their antibody-drug conjugate Datroway (datopotamab deruxtecan) signif...

Abivax Positive Data with Ulcerative Colitis Drug

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Abivax announces new Phase 3 data showing that its lead drug candidate, obefazimod, achieved clinically meaningful improvements ac...

FDA OKs Arcutis Zoryve for Pediatric Eczema

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FDA approves an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) cream 0.05% for treating mild to moderate atopic...

FDA Pilots Speedier Reviews for U.S.-Made Generics

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FDA unveils a new pilot program to prioritize the review of certain generic drug ANDAs in an effort to boost domestic pharmaceutic...

Makary Outlines Push to Modernize Drug Reviews

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FDA commissioner Marty Makary talks with CNNs Sanjay Gupta and says he wants to speed up the nations drug approval process without...

Brookings Questions FDAs New Voucher Program

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A new Brookings Institution commentary raises concerns about FDAs new Commissioners National Priority Voucher pilot program.

2nd Generic Mifepristone Approved, Prompting Backlash

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FDA approves the second generic copy of abortifacient mifepristone, a move that prompted mixed reactions from lawmakers and advoca...

Agency Posts Form-483 for India Vaccine Maker

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FDA posts a five-item FDA Form-483 after inspecting Covid-19 vaccine maker Serum Institute of Indias Maharashtra manufacturing fac...

Rocket Pharma Withdraws Gene Therapy BLA

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Rocket Pharmaceuticals withdraws its BLA for RP-L102 (mozafancogene autotemcel), an investigational gene therapy for treating Fanc...