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BD New Breast Biopsy System Cleared

[ Price : $8.95]

FDA clears a BD 510(k) for its EnCor EnCompass Breast Biopsy and Tissue Removal System, a new platform designed to allow clinician...

8 Observations in Shilpa Medicare 483

[ Price : $8.95]

FDA releases the form FDA-483 with eight observations from an inspection at Indias Shilpa Medicare drug manufacturing facility.

Chinese Firms Asked About Counterfeit GLP-1 Drugs

[ Price : $8.95]

The ranking member of a House Select Committee on competition with China writes to three Chinese drug companies asking for detaile...

Teclistamab Cuts Myeloma Risk of Progression by 71%: J&J

[ Price : $8.95]

Johnson & Johnson reports positive results from a late-stage clinical trial showing that its bispecific antibody therapy Tecvayli ...

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

[ Price : $8.95]

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

Compounder Says Lilly, Novo Nordisk Violate Antitrust

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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