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Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an i...[ Price : $8.95]
CDRH issues an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain ki...[ Price : $8.95]
CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Ac...[ Price : $8.95]
Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene ther...[ Price : $8.95]
A Friends of Cancer Research white paper recommends a new approach to support administered activity escalation and dosage optimiza...[ Price : $8.95]
FDA warns Indias Reliance Life Sciences about significant CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns Jabil Inc. about significant CGMP violations at its Pharmaceutics International unit in Cockeysville, MD.[ Price : $8.95]
Novartis and Bristol Myers Squibb confirm to BioSpace that they are suspending some CAR T candidate trials to evaluate adverse eve...