Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, ...
The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patients Imlifida...
T-MAXIMUM Pharmaceutical announced that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food an...
Symbiosis Pharmaceutical Services (Symbiosis), a leading sterile fill finish contract manufacturing organisation (CMO), has manufactured their first 10,0...
Measuring change in bone mineral density, rather than fracture occurrence, promises to speed development of new drugs to treat osteoporosis. FNIH Bi...
SynaptixBio, the only company licensed to commercialise a treatment for a rare, deadly disease, says the Priority Review Voucher scheme is a lifeline for...
Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announc...
Vanda Pharmaceuticals Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ims...
Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the EPO notified the...
Prilenia Therapeutics B.V. and Ferrer announced that the US Food and Drug Administration (FDA) has cleared the start of the pivotal, 500-patient, r...
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, announced that its next-generation TRK inhibitor, zurletrectinib (ICP-72...
SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, announced the launch of two s...
Resmed , the leading health technology company focused on sleep, breathing and care delivered in the home, announced it has received U.S. Food and Drug A...
Incyte announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INCA033989, a first-in-class muta...
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