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Former CBER Head Marks Joins Eli Lilly

[ Price : $8.95]

After being forced to resign in April, former CBER director Peter Marks accepts a job at Lilly Research Laboratories overseeing mo...

Clinical Hold Lifted on Neurizon ALS Drug

[ Price : $8.95]

FDA lifts a clinical hold on Neurizon Therapeutics on its lead experimental treatment for amyotrophic lateral sclerosis.

Priority Review for Orca Blood Cancer Cell Therapy

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FDA accepts for priority review an Orca Bio BLA for Orca-T, an investigational allogeneic T-cell immunotherapy for patients with c...

FDA Authorizes Cryoablation for Low-Risk Breast Cancer

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FDA grants IceCure Medicals de novo marketing authorization for the ProSense cryoablation system for treating early-stage, low-ris...

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...