FDA News

SOLON, Ohio--(BUSINESS WIRE)--Multi Radiance Medical (MRM), a global leader in Super Pulsed Laser therapy technology and photobiomodulation research, announces that the U.S. Food and Drug Administration (FDA) has granted NHN 510(k) clearance for the adjunctive use of the MR5 ACTIV PRO Super Pulsed Laser for the temporary relief of pain associated with lateral epicondylitis. Lateral epicondylitis (LE) is one of the most common causes of elbow pain, affecting an estimated 10.5 million adults annu...

BOSTON--(BUSINESS WIRE)--TIME named Will Ahmed to the inaugural 2026 TIME100 Sports list, recognizing 100 of the most influential figures shaping the global sports landscape. The recognition comes during a year of significant momentum for Ahmed and WHOOP. Under his leadership, WHOOP expanded its presence across global sports through partnerships with Paris Saint-Germain's men's and women's football teams, the Ryder Cup, and Scuderia Ferrari HP, while continuing to advance its mission of helping...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that the Company’s clinical program for fasedienol nasal spray for the acute treatment of social anxiety disorder has achieved the minimum patient exposures as recommended under ICH E1, the international regulatory...

AUSTIN, Texas--(BUSINESS WIRE)--Zetagen Therapeutics, a clinical‑stage biopharmaceutical company developing novel therapies for primary and metastatic breast cancer, today announced preliminary topline results from its Phase 2a clinical study evaluating ZetaMet™ (Zeta BC 003) in subjects with metastatic breast cancer (MBC) with lytic bone lesions. In this open‑label study, no skeletal‑related events (SREs) or fractures were observed, no treatment‑emergent adverse events (AEs) or serious adverse...

PALO ALTO, Calif.--(BUSINESS WIRE)--GEn1E Lifesciences Inc., a Phase 2 clinical-stage biotechnology company advancing AI-driven precision medicines for immunology, inflammation, and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to GEn-1123 for the treatment of Duchenne Muscular Dystrophy (DMD). The dual designations mark important regulatory milestones for GEn1E and sup...

EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Cronus Pharma LLC, a leader in animal health innovation, is excited to announce the release of its new Pimobendan Chewable Tablets, available for purchase in the U.S. veterinary market after June 9, 2026. This product is designed to support veterinarians in providing high-quality cardiac care for dogs. It is the first FDA-approved bioequivalent of Vetmedin®. About Pimobendan Chewable Tablets Indicated for the management of mild, moderate, or severe congest...

FOSTER CITY, Calif., & RAHWAY, N.J.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the primary efficacy endpoint at Week 48 was met in both the Phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in...

ST. LOUIS--(BUSINESS WIRE)--Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved coverage for FDA-approved ColoSense, a stool-based colorectal (CRC) screening test, within the National Coverage Determination (NCD) for colorectal cancer screening tests. Coverage for ColoSense provides Medicare's approximately 65 million eligible bene...

NEW ORLEANS--(BUSINESS WIRE)--insitro, the physical AI company unlocking causal human biology, today presented new preclinical data from its metabolic dysfunction-associated steatohepatitis (MASH) therapeutic development program during a podium presentation at the American Diabetes Association (ADA) 86th Scientific Sessions. The data demonstrate that liver-targeted silencing of IRS1 reduced fibrosis progression and injury-associated circulatory biomarkers in an industry-standard fibrogenic prec...

HYOGO, Japan--(BUSINESS WIRE)--JCR presented new clinical data in a poster session at the 18th International Symposium on MPS and Related Lysosomal Diseases, held June 4-7, 2026....