PEAK trial first ever study to demonstrate statistical significance over an active comparator in GIST patients, with bezuclastinib plus sunitinib combination demonstrating mPFS of 16.5 months and ORR ...
The FDA has accepted a New Drug Application (NDA) for Celcuity’s gedatolisib in hormone receptor positive (HR+), human ...
FDA grants Breakthrough Therapy designation to ianalumab for Sjögren disease after the monoclonal antibody showed significant disease improvement.
The FDA has accepted the supplemental Biologics License Application (BLA) for ropeginterferon alfa-2b-njft (Besremi), a ...
The healthcare giant just took a major step that could reshape its MedTech business and boost its dividend track record.
FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026MINNEAPOLIS, (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: ...
Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date set for July 17, 2026. The drug is intended for HR+/HER2–, PIK3CA wild-type ...
FDA has requested the HOPE-3 clinical study report (CSR) as part of the BLA review processCompany expects to submit updates to the BLA in ...
Hemostemix receives US FDA support for its basket protocol approach: Calgary, Alberta Tuesday, January 20, 2026, 18:00 Hrs [IST] Hemostemix Inc., the leading autologous stem cell ...
Lipocine Inc. , a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that enrollment and participant ...
ImmunityBio, Inc. , a clinical-stage immunotherapy company, today announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company's supplemental Biologics License ...
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