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Scholar Rock Plans BLA Resubmission for Apitegromab

[ Price : $8.95]

Scholar Rock plans to resubmit its BLA seeking approval of apitegromab, a first-in-class muscle-targeted therapy for spinal muscul...

IND Review Procedures SOPP

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CBER publishes a Standard Operating Policy and Procedure on IND administrative processing and review management procedures.

Compounder Says Lilly, Novo Nordisk Violate Antitrust

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Strive Specialties, a compounding pharmacy, says in a suit filed in a Texas federal court that Eli Lilly and Novo Nordisk are viol...

Inspection Flags Sanitation, Quality Control Lapses at Biocon

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FDA cites Biocon Biologics for a series of manufacturing and quality control deficiencies following an inspection of the companys ...

2 Voucher Program Drug Reviews Delayed: Reuters

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Reuters reports exclusively that FDA medical reviewers have slowed reviews on two drugs in the new Commissioners National Priority...

Jazz Unloads Priority Voucher for $200 Million

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Jazz Pharmaceuticals sells its FDA Priority Review Voucher for $200 million to an undisclosed purchaser.

Bumpus Named Chief Scientific Officer at Charles River Labs

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Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as senior vice president and chief sci...

Expanded Use Cleared for Robotic Cochlear Implant Insertion

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FDA clears an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion ...

FDA Hits Altor Bio Over Promo Violations

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FDA sends an untitled letter to Altor BioScience, alleging that promotional Web pages for bladder cancer drug Anktiva are false or...

FDA, EMA Drug Development AI Principles

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FDA and the European Medicines Agency publish their collaborative 10 guiding principles for using artificial intelligence in drug ...