Newsroom | 54540 results

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement: Just before 6:00 p.m. ET today, the U.S. Food and Drug Administration (FDA) issued a press release announcing an investigation into the death of an eight-year-old Duchenne muscular dystrophy (Duchenne) patient who had received ELEVIDYS (delandistrogene moxeparvovec) gene therapy. The death of this patient was deemed unrela...

GLASSBORO, N.J.--(BUSINESS WIRE)--Two transformative healthcare announcements mark a new era for New Jersey’s innovation economy—with GSVP emerging as a key catalyst behind both....

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced that four abstracts highlighting clinical progress across its botensilimab and balstilimab immunotherapy programs have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2025, taking place in Berlin, Germany from October 17-21. The highlight is an oral presentation that will feature emerging survival plateaus from a study of botensilimab plus balst...

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause...

NAARDEN, Netherlands & WALTHAM, Mass. & BARCELONA, Spain--(BUSINESS WIRE)--Prilenia Therapeutics B.V. and Ferrer today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorization for pridopidine’s marketing authorization application for Huntington’s disease (HD). We are disappointed, but undeterred in our commitment to bring what we believe is an effective therapy to patients and will explo...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, acknowledges that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the conditional marketing authorization (CMA) for ELEVIDYS (delandistrogene moxeparvovec) in ambulatory individuals ages three to seven years for the treatment of Duchenne muscular dystrophy (DMD). “While we are disappointed by the CHMP’s negative opinion,...

NEW YORK--(BUSINESS WIRE)--Schrödinger (Nasdaq: SDGR) will report its second quarter 2025 financial results on Wednesday, August 6, 2025, after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET. The live webcast can be accessed in the “Investors” section of Schrödinger’s website and will be archived for approximately 90 days following the event. About Schrödinger Schrödinger is transforming molecular discovery with its computational platform, which...

BOSTON & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Leveragen, a Boston-based biotechnology company pioneering next-generation in vivo antibody discovery platforms, announced today a strategic collaboration with Propeller Bio, a newly launched biotechnology company focused on antibody and protein-based therapeutics. As part of the partnership, Propeller Bio will support the continued development of Leveragen’s antibody discovery platforms through a strategic investment. In turn, Propeller wi...

PLYMOUTH, Mass.--(BUSINESS WIRE)--The Vascular Care Group Welcomes Dr. Scott James as Newest Physician Partner...

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for sebetralstat, a novel oral plasma kallikrein inhibitor, for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The European Commission (E...