FDA News

NEW YORK--(BUSINESS WIRE)--QuantalX™ Neuroscience, the company translating brain signals into better care, today announced that it has been named a finalist in the 2026 Digital Health & AI Awards in the Rising Star – Brain Health category. The Digital Health & AI Awards recognize innovations shaping the future of healthcare. Neurologists can assess symptoms, review imaging and identify biomarkers, but they have lacked a standardized way to directly measure how brain networks are functio...

CAMP HILL, Pa.--(BUSINESS WIRE)--Forma Medical Inc. announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 12,751,749, titled “System for Joint Fixation of Extremity Bone and Related Methods.” The patent, which issued October 6, 2026, covers surgical methods for what Forma calls minimally invasive plate arthrodesis, or MIPA™, in which a plate is introduced and secured across a joint of the foot through small incisions rather than a traditional open exposure. Fusion...

SILOAM SPRINGS, Ark. & NEW YORK--(BUSINESS WIRE)--Rotary Action Group Addiction Prevention North America (RAGAPNA) today announced a collaboration with Oar Health, a telehealth platform offering medications for alcohol use disorder (MAUD), including FDA-approved naltrexone. Together, RAGAPNA and Oar Health will deliver training that equips Rotarians across the U.S. to educate their communities about MAUD, then connect the people they reach to safe, effective FDA-approved medications. Excessive...

PALO ALTO, Calif.--(BUSINESS WIRE)--Overture Life, the first company to achieve live births from both robotic fertilization and robotic egg freezing, today announced the U.S. commercial introduction of ICSI.A, its robotic intracytoplasmic sperm injection (ICSI) workstation, following completion of FDA establishment registration and device listing. ICSI.A is a Class II medical device in a category exempt from FDA premarket notification; with registration and listing complete, Overture has satisf...

NEW YORK--(BUSINESS WIRE)--TG Therapeutics, Inc. (NASDAQ: TGTX), today announced several updated poster presentations at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting. The presentations include seven-year follow up data from the ULTIMATE I & II trials, Phase 1 subcutaneous BRIUMVI data, Phase 3 ENHANCE trial data, an update from the ENABLE real world study, and more presentations highlighting BRIUMVI data. Additionally, the abstract is now available for the late-breaking oral presen...

LATHAM, N.Y.--(BUSINESS WIRE)--AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options, and improving quality of life for patients, today announced two milestones for irreversible electroporation (IRE), the non-thermal ablation technology delivered by the NanoKnife System. The first is the publication of results from the DIRECT study in The Oncologist, in...

SINGAPORE--(BUSINESS WIRE)--PVP Labs to present four Taphalgin® (lumekefamide) scientific posters at the IASP 2026 World Congress on Pain in Bangkok, Thailand....

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced completion of the database lock for Cohort A of QUILT-2.005 (NCT02138734), its randomized, controlled, registrational trial evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve NMIBC. The chemotherapy-free combination is delivered directly into the bladder. The database lock follows the...

CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner GSK today announced that the U.S. Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis...

PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus (HBV) surface antigen (HBsAg)...