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Fast Track for 7 Hills Pharma Cancer Drug

[ Price : $8.95]

FDA grants fast track designation for 7 Hills Pharmas lead clinical-stage immunosuppressant to treat some malignant melanomas.

CDER Meeting on Naloxone Availability

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FDA and the Reagan-Udall Foundation announce a 3/29 virtual public workshop to discuss critical questions around access to naloxon...

Too Few High-Risk CV Device Post-Approval Studies

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Despite a statutory mandate, researchers say FDA has not increased post-approval trials with clinical endpoints for high-risk card...

Myrtelle Gets 3 FDA Designations for Gene Therapy

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FDA grants Myrtelle a Fast Track, Rare Pediatric Disease, and Orphan Drug designations for its lead clinical-stage gene therapy, r...

Kairos Pharma Glioblastoma Trial OKd by FDA

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FDA approves a Kairos Pharma IND to begin a clinical trial of its activated T cell therapy (KROS 201) in patients with recurrent g...

Comments Sought on Pharma Quality/CMC Data Exchange

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Federal Register notice: FDA seeks comments on its draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data...

2 WuXi FDA-483s Released

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FDA releases the FDA-483s issued following two separate 2021 inspections at Chinas WuXi Biologics.

2 Former JHL Biotech Execs Sentenced

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Two former JHL Biotech executives are sentenced to prison time and supervised release for conspiring to steal Genentech trade secr...

Celltrion Covid Test Recall is Class 1

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FDA says a Celltrion USA recall of a Covid-19 rapid test due to a high rate of false-positive results is Class 1.

Info Collection Extenso on Device Accessories

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FDA seeks comments on an information collection extension for medical device accessories.