Novartis’ Fabhalta® (iptacopan) Wins Third FDA Approval for C3G Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved oral Fabhalta® (iptacopan) for the treatment of adults with C3 glomerulopathy (C3G) to reduce proteinuria. This milestone makes…
Omeros Updates Phase 3 Zaltenibart PNH Trial Omeros Corporation has announced that site activation for enrollment is underway in its Phase 3 clinical trial program evaluating zaltenibart (OMS906) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart is an investigational…
NeuroSense Therapeutics Advances Toward Early Canadian Commercialization of ALS Drug NeuroSense Therapeutics Ltd. has announced significant progress toward the early commercialization of PrimeC in Canada. According to a Form 6-K filed with the SEC this morning, Health Canada has invited…
InnoCare Doses First Patient in Phase III Trial of ICP-488 for Psoriasis in China InnoCare Pharma, a leading biopharmaceutical company dedicated to developing innovative treatments for cancer and autoimmune diseases, has announced a significant milestone in its clinical development efforts.…
Shift Bioscience Strengthens Leadership Team to Accelerate Rejuvenation Therapeutics Development Shift Bioscience, a pioneering biotechnology company utilizing an AI-powered virtual cell platform to combat age-related diseases, has announced the strategic appointments of Jill Reckless, Ph.D., as Translation Advisor, and Laurence…
WAINZUA (Eplontersen) Receives EU Approval for Hereditary ATTR Amyloidosis Treatment Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that WAINZUA (eplontersen), developed in collaboration with AstraZeneca, has been approved by the European Union (EU) for the treatment of hereditary transthyretin-mediated amyloidosis…
Viridian Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative therapies for serious and rare diseases, today announced that its Compensation Committee, consisting of a…
Sensorion Completes Patient Enrollment in NOTOXIS Phase 2a Clinical Trial of SENS-401 for Cisplatin-Induced Ototoxicity Prevention Sensorion, a pioneering clinical-stage biotechnology company focused on the development of innovative therapies for hearing loss disorders, has announced the completion of patient enrollment…
Bicycle Therapeutics Announces Inducement Grants Bicycle Therapeutics plc (NASDAQ: BCYC), a pioneering biotechnology company focused on developing a new class of therapeutics known as Bicycle® molecules, announced that on March 3, 2025, the Compensation Committee of the company’s Board of…
FDA Accepts sBLA for Genentech’s Gazyva in Lupus Nephritis Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA)…
Shorla Oncology Expands U.S. Presence with New Sales & Market Access Teams Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, has officially launched a dedicated sales force and market access teams to support the commercial rollout of IMKELDI, the first…
Medable Secures CNIL Approval, Paving the Way for Digital Clinical Trials in the EU Medable Inc., a global leader in clinical development technology, has reached a significant regulatory milestone with the approval of its eConsent and electronic Clinical Outcome Assessment…
