FDA News

BAD HOMBURG, Germany--(BUSINESS WIRE)--Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to the reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration. The applications wer...

ROTKREUZ, Switzerland--(BUSINESS WIRE)--Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults w...

CHICAGO--(BUSINESS WIRE)--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines, biologics, fertility products and branded medicines, today announced that the U.S. Food and Drug Administration (“FDA”) has approved Garzulys™ (insulin aspart-fsan) injection, a biosimilar to NovoLog® (insulin aspart). Emerge Bioscience Pte. Ltd. (“Emerge”) is the holder...

DANVILLE, Calif.--(BUSINESS WIRE)--RecovryAI completes the patient phase of its pivotal trial: 525 patients and 43,000+ clinical conversations ahead of a planned FDA De Novo filing....

NEW YORK--(BUSINESS WIRE)--Magic Molecule, a leading hypochlorous acid skincare brand from Magic Science Corporation, today announced that its bestselling Daily Skin Spray will be sold at more than 4,500 Walmart stores nationwide and on Walmart.com, bringing Magic Molecule’s retail footprint to more than 16,500 locations across the country. Available in both 3.4-ounce and 8-ounce sizes, the FDA-cleared Daily Skin Spray started rolling out to Walmart’s skincare department this week. The nationwi...

FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter, “Shionogi”) today announced the four-year anniversary of RADICAVA ORS® (edaravone), the only oral formulation of edaravone approved by the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS). To date, RADICAVA ORS has been prescribed by approximately 1,640 physicians in the U.S., with about 810 physician...

VIENNA, Va.--(BUSINESS WIRE)--Leading oncology journal accepts for publication new CEL-SCI Multikine Phase 3 data....

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sumitomo Pharma America, Inc. (SMPA) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to enzomenib (DSP-5336) for the treatment of patients with acute lymphoblastic leukemia (ALL). Enzomenib is an investigational, oral, small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and gro...

OSAKA, Japan--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) announced financial results for the first quarter of fiscal year 2026 (April 1, 2026 to June 30, 2026), marking a period of disciplined execution and operational momentum. Takeda leveraged the resilient performance of its core in-line portfolio to support its long-term strategy, advancing commercial launch preparations and driving critical R&D pipeline milestones. With a clear operational trajectory established in the first quarter...

NEWCASTLE, England--(BUSINESS WIRE)--Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS04, a CA242-directed ADC, enabling assessment in a Phase 1 trial in patients with gastrointestinal (GI) cancers. CA242 is a tumour-specific glycotope which is strongly expressed in a variety of GI cancers including the majority of color...