Tag: FDA

SAN DIEGO, July 25, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, announced today that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-12 (the “Reverse Stock Split”). The Company’s common stock is expected to commence trading on a split-adjusted basis when the NYSE American market opens on August 5, 2025 under the existing symbol of “CLDI.” The new CUSIP number for the Company’s common stock following the Reverse Stock Split will be 320703 408.

As Consumer Demand Surges for Lab-Tested Botanical Products, Super Speciosa Responds With a Timely Tincture Update and GMP-Backed Transparency

A Natural Supplement Trend in 2025, Menovelle Helps Women Support Hormonal Balance and Metabolic Energy Without Hormone Therapy or Stimulants

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $100,000 In Sarepta To Contact Him Directly To Discuss Their Options

ATLANTA, July 25, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse information, including allegations that: (1) Defendants recklessly overstated the IGNYTE trial’s prospects, given material issues that defendants knew or should have known of, which resulted in the FDA deeming the IGNYTE trial inadequate and not well-controlled; and (2) as a result, defendants’ statements about Replimune’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all times.

CONSHOHOCKEN, Pa., July 25, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), announced today that it will release its second-quarter 2025 financial results on Wednesday, Aug. 5, 2025, prior to the open of the U.S. financial markets.

NEW YORK and MAINZ, GERMANY, July 25, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY^® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”²

NEW YORK und MAINZ, Deutschland, 25. Juli 2025 — Pfizer Inc. (NYSE: PFE, „Pfizer“) und BioNTech SE (Nasdaq: BNTX, „BioNTech“) gaben heute bekannt, dass der Ausschuss für Humanarzneimittel (Committee for Medicinal Products for Human Use, „CHMP“) der Europäischen Arzneimittel-Agentur (European Medicines Agency, „EMA“) eine positive Beurteilung für die Marktzulassung (Marketing Authorization) des an LP.8.1 angepassten monovalenten COVID-19-Impfstoffs (COMIRNATY^® LP.8.1) der Unternehmen für die aktive Immunisierung zur Vorbeugung von COVID-19 verursacht durch SARS-CoV-2 bei Personen ab 6 Monaten ausgesprochen hat. Die Anpassung basiert auf der Empfehlung der Notfall-Taskforce (Emergency Task Force, „ETF“) der EMA, die vorschlägt, COVID-19-Impfstoffe zu aktualisieren, um die LP.8.1-Variante für die Impfkampagne 2025-2026 abzudecken. Die Notfall-Taskforce erklärte: „Eine Anpassung an LP.8.1 wird dabei helfen, die Wirksamkeit der Impfstoffe gegen das sich fortlaufend weiterentwickelnde SARS-CoV-2 aufrechtzuerhalten.“²