MASITINIB RECEIVES FDA AND EMA AUTHORIZATION FOR CONFIRMATORY PHASE 3 TRIAL IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER, WITH BIOMARKER-DRIVEN PATIE...
WeightWatchers Clinic Members Can Access FDA-Approved Wegovy® for $299 in July, a $200 Savings Offer to Improve Access as WeightWatchers’ Trust...
Bristol Myers Squibb’s announcement that the US Food and Drug Administration has approved the removal of REMS programs an...
Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant reci...
Novadip Biosciences, a late-stage clinical biotechnology company specializing in regenerative medicine, announces that the FDA has granted the Regenerative...
FDA submission seeks approval for investigational gadolinium-based contrast agent (GBCA) gadoquatrane for contrast-enhanced magnetic resonance imagin...
Medicovestor, Inc., a biotechnology company advancing next-generation antibody-drug conjugates (ADCs), announced that the U.S. Food and Drug Administrati...
Fast Track status enables expedited regulatory review timelines and supports the development of recombinant human plasma gelsolin (rhu-pGSN), a novel imm...
The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, a novel, advanced, oral, reversible Bruton's tyrosine kin...
Kura Oncology, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted Kura’s New Drug Application (NDA) seeking full approva...
SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infe...
Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing an...
ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study If approved, DARZALEX FASPRO® w...
-Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi®, a recombinant DNA-derived, extended half-life factor VIII conce...
© 2025 Biopharma Boardroom. All Rights Reserved.
