Tag: FDA

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

Paris, France – June 12, 2025

Enterome SA, a clinical-stage company developing first-in-class OncoMimics™ immunotherapies to treat cancer, has raised $19 million in a new private financing to advance its lead clinical program EO2463 OncoMimics™ immunotherapy to treat indolent non-Hodgkin lymphoma (iNHL). The new funds will be used to expand and finalize the ongoing Phase 1/2 SIDNEY clinical trial of EO2463 and prepare the candidate for a registrational trial.

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).

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against PepGen, Inc. (“PepGen” or the “Company”) (NASDAQ: PEPG) in the United States District Court for the Eastern District of New York on behalf of all persons and entities who purchased or otherwise acquired PepGen securities between March 7, 2024 and March 3, 2025, both dates inclusive (the “Class Period”). Investors have until August 8, 2025 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- The following statement is being issued by Levi & Korsinsky, LLP:

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of PepGen Inc. (NASDAQ: PEPG) between March 7, 2024 and March 3, 2025, both dates inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 8, 2025.