Alvotech’s revenues for 2025 are expected to drop after it received a complete response letter from the FDA regarding its biosimilar AVT05. Credit: Piotr Swat/ Shutterstock.com. Alvotech’s inflammation-targeting biosimilar AVT05 has been rejected by the U.S. Food and Drug Administration (FDA) because of issues with the company’s manufacturing facility in Reykjavik, Iceland. The biosimilar-focused biotech was anticipating that AVT05 would be the first-to-market biosimilar of Johnson & Johnson’s S

The Company received an upfront payment of €10.5 million in July 2025 after the signature of an exclusive license and distribution agreement with Clinigen. Subject to approval and grant of a Marketing Authorization by the European Medicines Agency, it has the potential to facilitate patient access of Xervyteg®(MaaT013) across Europe. The Company received €3.5 million in October 2025 from the successful drawdown of Tranche A of the €37.5 million, 4-tranche financing from the European Investment B

iStock, Andrii Yalanskyi Sarepta nevertheless plans to push for full FDA approval of Vyondys 53 and Amondys 45 based on what it said are “encouraging trends” in efficacy. The challenges just keep coming for Sarepta Therapeutics. The company reported that its exon-skipping therapies Vyondys 53 and Amondys 45 failed to significantly improve motor function in patients with Duchenne muscular dystrophy. Nevertheless, Sarepta will seek full FDA approval of the treatments, announcing the plans durin

NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. “We are thrilled that 204 new patients have received IBTROZI during our first full quarter as a commercial-stage company,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Our early launch

FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the identification, acquisition, development and commercialization of novel therapies for debilitating rare and orphan diseases, today announced that it will participate in the following upcoming investor conferences: 2025 Stifel Healthcare Conference Company presentation - Tuesday, November 11 th , starting at 8:40 a.m. ET Company presentation - Tuesday, November 11 th , star

HOUSTON, Nov. 3, 2025 /PRNewswire/ -- AAVivo, Inc., a pioneering biotechnology company developing novel, precision targeted biotherapeutics to enable in vivo generation of CAR-T cells, today announced a presentation at the Society for Immunotherapy of Cancer 2025, which is being held November 5-9, in National Harbor, MD. AAVivo will present a poster titled, "In Vivo Generation of CD19-Specific CAR-T Cells Using a Novel AAV Gene Therapy Platform to Treat B Cell Malignancies". The poster describes

Delivered record total third quarter revenue of $851 million, an increase of 20% on a reported and core revenue basis, including Screening revenue of $666 million and Precision Oncology revenue of $184 million Raised full-year 2025 revenue and adjusted EBITDA guidance midpoints by $78 million and $10 million, respectively Generated record cash from operations and free cash flow Launched Cancerguard ® , the company's multi-cancer early detection test, for patients in the United States MADISON, Wi

NEW YORK and ARLINGTON HEIGHTS, Ill., Nov. 3, 2025 /PRNewswire/ -- Arsenal Capital Partners ("Arsenal"), a leading private equity investment firm that specializes in building market-leading industrial growth and healthcare companies, today announced it has completed the acquisition of ThermoSafe from Sonoco Products Company ("Sonoco") (NYSE: SON). Continue Reading Based in Arlington Heights, Illinois, ThermoSafe is a global leader in temperature assurance technologies that ensure the safe and ef

Approved indication: KYGEVVI® (doxecitine and doxribtimine) powder for oral solution (2g/2g) is approved for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years.1 Survival benefit: Treatment reduced the overall risk of death from the start of treatment by approximately 86% (95% CI: 61%, 96%).1 Burden of disease: TK2d is an ultra-rare, life-threatening, genetic mitochondrial disease characterized by progressiv

“Pediatric Frontlines” features physicians and researchers exploring breakthroughs that are shaping the future of children’s health At the core of our care are our providers and researchers, so we’re seeking to highlight what Shriners Children's brings to the medical community in terms of advancements and best practices.” — Shriners Children's Chief Marketing and Communications Officer Mel Bower TAMPA, FL, UNITED STATES, November 3, 2025 / EINPresswire.com / -- Shriners Children’s, the internati