Tag: FDA

SOUTH SAN FRANCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, announced today that members of its senior management team will participate in the H.C. Wainwright “HCW@Home” Series taking place virtually on Wednesday, June 25, 2025, at 12:00 PM ET.

PALO ALTO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, today announced that its Board of Directors (the “Board”) has approved a deferral of the previously announced record date of May 2, 2025 for the Company’s previously announced dividend of Scilex preferred stock (the “Dividend”) to its stockholders and certain other securityholders of Scilex. The new record date for the Dividend will be such later date to be determined in the sole discretion of the Board (such later record date as so determined by the Board, the “New Record Date”). The Board retains the right to continue to change any New Record Date (and therefore any related payment date for the Dividend) and the ability to revoke the Dividend.

LOUISVILLE, Ky., June 23, 2025 (GLOBE NEWSWIRE) -- Onco360^®, the nation’s leading independent specialty pharmacy, has been selected as a specialty pharmacy partner by Deciphera Pharmaceuticals, LLC for ROMVIMZA^™ (vimseltinib), which has been approved by the U.S. Food and Drug Administration for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.¹ This indication was approved based on the Phase III MOTION study of ROMVIMZA in patients with tenosynovial giant cell tumor (TGCT).²

SAN FRANCISCO, June 23, 2025 (GLOBE NEWSWIRE) -- A securities class action lawsuit styled Ho v. Rocket Pharmaceuticals, Inc., et al., No. 3:25-cv-10049 (D. N.J.) has been filed and seeks to represent investors who purchased or otherwise acquired Rocket Pharmaceuticals securities between February 27, 2025 and May 26, 2025.

Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic^® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial.

NEW YORK, June 23, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  UroGen Pharma Ltd. (“UroGen” or the “Company”) (NASDAQ: URGN).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG

REYKJAVIK, Iceland and LONDON, June 23, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.