News

Ultragenyx Initiates Rolling Submission of Biologics License Application (BLA) to U.S. FDA for DTX401 AAV Gene Therapy for the Treatment of Glycogen Storage Disease …

Company expects to complete BLA submission in the fourth quarter of 2025NOVATO, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) -- ...

EYLEA HD® (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® ...
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NMPA Accepted Essex's Biologics License Application for EB12-20145P (HLX04-O) for the Treatment of Wet Age-Related Macular Degeneration

Essex Bio-Technology Limited (“Essex” or the “Group”, Stock Code: 1061.HK) is pleased to announce that a Biologics License Application (“BLA”) for EB12-20145P (HLX04-O), a recombinant ...

Ultragenyx Pharmaceutical Inc.: Ultragenyx Initiates Rolling Submission of Biologics License Application (BLA) to U.S. FDA for DTX401 AAV Gene Therapy for the Treatment of ...

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the initiation of a rolling submission of a Biologics License Application (BLA) to the ...
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Ultragenyx Begins FDA Application for DTX401 Gene Therapy

Detailed price information for Ultragenyx Pharmaceu (RARE-Q) from The Globe and Mail including charting and trades.
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Ocugen shares update on upcoming BLA submissions in three indications

In this Healio Video Perspective from the Retina World Congress, Huma Qamar, MD, MPH, of Ocugen, overviews programs for ...

Regeneron Pharmaceuticals, Inc.: EYLEA HD (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates ...

CG Oncology’s Bladder Cancer Drug Shows Strong Clinical Data, Drives Optimism Despite Price Target Cut

CG Oncology’s lead investigational drug, cretostimogene grenadenorepvec, an oncolytic immunotherapy, showed promising results ...

Novavax Strengthens Position with Vaccine Approval and Sanofi Partnership

Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company focused on recombinant protein-based vaccines using nanoparticle and ...

Savara upgraded at H.C. Wainwright on potential refiling of marketing application

Savara (SVRA) stock was upgraded to Buy at H.C. Wainwright, citing higher prospects for a resubmitted marketing application ...
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RemeGen and Santen Enter into Exclusive Licensing Agreement for Ophthalmic Innovative Drug RC28-E in Greater China and Asian countries

RemeGen Co., Ltd. (Stock Code: 688331.SH/09995.HK, 'RemeGen'), a leading Chinese biopharmaceutical company, announced today ...
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National pediatrics group splits with RFK Jr. on Covid vaccinations

The American Academy of Pediatrics is splitting from the federal government in its recommendations on which children should ...