MELBOURNE, Australia — Amplia Therapeutics Limited, is pleased to announce that the U.S. FDA have cleared Amplia’s IND application for a trial of Amplia’s best-in-class focal adhesion kinase (FAK) inhibitor narmafotinib in pancreatic cancer. The proposed trial will explore the safety, tolerability and efficacy of a combination of narmafotinib with...
Latest News
AMSTERDAM, the Netherlands & BOSTON, Mass. — VectorY Therapeutics, a leader in vectorized antibody therapies for neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company to proceed with the PIONEER-ALS Phase 1/2 Trial of VTx-002. VTx-002 is a first-in-class vectorized antibody targeting TDP-43...
Washington DC — FDA announced a pilot program, Support for clinical Trials Advancing Rare disease Therapeutics (START), intended to support development of novel drug and biological products for rare diseases. The agency is establishing a pilot program for a limited number of sponsors, intended to allow for more regular communication...
RAHWAY, N.J. – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg. WINREVAIR, an...
PLAINSBORO, N.J. — Novo Nordisk announced today that the US Food and Drug Administration (FDA) approved Alhemo® (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B (HA/HB) without inhibitors, expanding...
SAN FRANCISCO, CA – Jaguar Health, Inc. (NASDAQ:JAGX) family company Napo Pharmaceuticals (Napo) today announced that, based on the U.S. Food and Drug Administration (FDA) support for Napo’s protocol amendment for its clinical trial to evaluate the safety and efficacy of its novel crofelemer powder-for-oral-solution formulation in pediatric patients with intestinal...
Parc d’Innovation, Illkirch, France – Transgene (Euronext Paris: FR0005175080) announces that it recently met with the U.S. Food and Drug Administration (FDA) for an end of Phase II meeting when results of its TG4010 controlled phase IIb clinical trial in non-small-cell lung cancer (NSCLC) were reviewed. As per the minutes...
SAN FRANCISCO, Calif. — Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. (“Biostar,” stock code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that its core pipeline product Utidelone has once again been...
NEEDHAM, Mass. — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to FORZINITY™ (elamipretide HCl) to improve muscle strength in...
Ridgefield, Conn. and Ingelheim, Germany — The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.1 This indication is...