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Complete Response Letter on Ultomiris sBLA

[ Price : $8.95]

FDA issues Alexion a complete response letter on a supplemental BLA for long-acting C5 complement inhibitor Ultomiris and its use ...

Guide on Drug Supply Chain Security

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled DSCSA Standards for the Interoperable Exchange of Informati...

FDA OKs Boston Scientifics Watchman FLX Pro

[ Price : $8.95]

FDA approves Boston Scientifics latest generation of its Watchman FLX Pro Left Atrial Appendage Closure device.

Strong Response in New Moderna Covid Vaccine

[ Price : $8.95]

Moderna says its updated Covid-19 vaccine demonstrated a strong response against the new BA.2.86 variant that is being closely wat...

FDA, Flatiron Health Real-world Data Pact

[ Price : $8.95]

FDAs Oncology Center of Excellence and Flatiron Health renew a five-year collaboration to jointly develop and implement specific r...

Breakthrough Status on Auto Glucose Device

[ Price : $8.95]

FDA grants Admetsys a breakthrough device designation for its automated glucose control and continuous blood diagnostics system.

Tivdak Confirmatory Trial Meets Primary Endpoint

[ Price : $8.95]

Seagen and Genmab report that their Phase 3 innovaTV 301 trial in recurrent or metastatic cervical cancer patients who received Ti...

Appeals Court Reverses Ivermectin Suit Dismissal

[ Price : $8.95]

The 5th Circuit Court of Appeals overrules a Texas federal court and says a suit by three doctors against FDA and HHS and their to...

Techsomed Ablation Planning Software Cleared

[ Price : $8.95]

FDA clears a Techsomed 510(k) for its VisAble.IO software intended to assist physicians in planning liver ablation procedures and ...

CGMP Violations at Lex, Inc.

[ Price : $8.95]

FDA warns Medley, FL-based Lex, Inc., about repeat CGMP violations in its production of finished drugs as a contract facility.