iStock, May Lim The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines. The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously on Thursday for a monovalent COVID-19 shot that includes coverage of the virus’ JN.1 lineage, the same recommendation it made last year. But looming over Thursday’s discussions—Leerink analysts in a note called it “the elephant in the room—was the FDA’s recently announ

iStock, beast01 Analysts were effusive about Merus’ new HNSCC data, writing that petosemtamab could “become the standard of care” in the first-line setting for this indication. Merus’ investigational bispecific antibody petosemtamab, when combined with Merck’s mega-blockbuster Keytruda, led to a nearly 80% overall survival rate when used as a frontline treatment option for certain patients with head and neck cancer, according to a Phase II readout posted Thursday. Writing to investors early o

VANCOUVER, May 23rd, 2025 – TheNewswire - Aequus Pharmaceuticals Inc. (TSX-V: AQS) (“Aequus” or the “Company”), a specialty pharmaceutical company focused on bringing healthcare solutions to Canadians through licensing and partnerships, and Luvo Medical Technologies Inc. (“Luvo”), today announce the signing of an Asset Purchase Agreement for the sale of Zimed® PF (the “Transaction”). Unless otherwise noted, all figures are in Canadian currency. “Since Zimed® PF was launched in 2023 in collaborat

ISLAMABAD, May 22, 2025 /PRNewswire/ -- In a groundbreaking move to elevate clinical diagnostics nationwide, MindHYVE.ai™, a U.S.-based pioneer in orchestrated agentic AI and swarm-intelligent systems, has signed a formal Memorandum of Understanding (MoU) with Islamabad Diagnostic Centre (IDC). The collaboration will see the deployment of Chiron and Ava-AutoNarrator™—two proprietary, AGI-powered agents—across IDC's core diagnostic workflows. Continue Reading Belal Faruki, CEO of MindHYVE.ai™, an

Poster presentation to highlight the ongoing global Phase 3 ASP-1929-381 study at ASCO 2025 Global patient enrollment continues, with Taiwan now actively enrolling following the U.S., and Japan expected to follow as part of global study start-up SAN DIEGO, May 22, 2025 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, today announced that it will present a Trial in Progress poster at the 2025 America

RESEARCH TRIANGLE PARK, N.C., May 22, 2025 /PRNewswire/ -- Bantam Pharmaceutical, a drug discovery and development company targeting selective modulation of mitochondrial dynamics in cancer, today announced that its Trial in Progress abstract has been accepted for presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, which is being held May 30 – June 3, 2025 at the McCormick Place Convention Center in Chicago, Illinois. The poster will highlight the company's ongo

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos Summary Company Announcement Date: May 21, 2025 FDA Publish Date: May 22, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description The product contains undeclared Dexamethasone, Diclofenac and Omeprazole Company Name: UMARY USA Brand

The FDA has approved Johnson & Johnson's anti-FcRn antibody, nipocalimab, for the treatment of generalized myasthenia gravis. The drug will be sold under the brand name IMAAVY. This approval positions J&J to challenge leading competitors in the myasthenia gravis market, such as AstraZeneca, which markets the monoclonal antibodies SOLIRIS and ULTOMIRIS. J&J will also be competing with Argenx's VYVGART and UCB's RYSTIGGO and ZILBRYSQ. LAS VEGAS, May 22, 2025 /PRNewswire/ -- Myasthenia gravis is an

REDWOOD CITY, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Soleno’s Marketing Authorization Application (MAA) seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets (previously referred to as DCCR) for the treatment of adults and children four years and older with Prader-Willi syndrome (PWS) who have hyperphagia ha

Approximately a year after the FDA rejected its previous approval submission, Abeona announced that the agency had approved ZEVASKYN, its autologous cell-based gene therapy for both adult and pediatric patients with RDEB. This approval marks Abeona's entry into the commercial gene therapy market for dystrophic epidermolysis bullosa. LAS VEGAS, May 22, 2025 /PRNewswire/ -- Dystrophic epidermolysis bullosa (DEB) is one of the main subtypes of epidermolysis bullosa, a group of genetic skin disorder