Tag: clinical studies

Data reported from the ongoing ATALANTA-1 Phase 1/2 study in a heavily pretreated relapsed refractory non-Hodgkin’s Lymphoma (R/R NHL) patient population demonstrate low rates of high-grade toxicities

BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte^®. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. Launch of this product is planned for the third quarter of 2025.

- AGA2115 also received Orphan Drug Designation from European Medicines Agency

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on continued momentum with United States Food and Drug Administration (FDA) regarding both accelerated approval pathway for Revascor^® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation, and label extension for Ryoncil^® (remestemcel-L-rknd) in adults with steroid refractory acute graft versus host disease (SR-aGvHD).

Alvotech (NASDAQ: ALVO, ALVO-SDB, the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the completion of a private placement that was carried out on June 4, 2025, directed to Swedish and international institutional investors. About 40 institutional investors participated in the placement. About 60% of the demand came from institutional investors based in Sweden, Norway or the UK, and about 30% from US-based funds. Over 80% of the shares and Swedish Depositary Receipts (SDRs) allocated in the placement, were sold to investors that were not previously shareholders in Alvotech.