FDA News

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS...

SANTA ROSA, Calif.--(BUSINESS WIRE)--Endologix LLC, a privately held, global medical device company focused on advancing innovative therapies for the interventional treatment of vascular disease, today announced the acquisition of the Pounce™ Thrombectomy System from Surmodics, Inc. The transaction closed on May 18, 2026. The Pounce System is an FDA-cleared, fully mechanical thrombectomy system for the non-surgical removal of thrombi and emboli from peripheral arteries. Built around proprietary...

NEW YORK--(BUSINESS WIRE)--Today, Sunrise Group, a pioneer in medical device innovation and sleep care, announced that the new generation of its home sleep test, Sunrise Air, has officially received FDA clearance. This clearance marks a major step forward in Sunrise’s mission to expand access to high-quality sleep care by providing a best-in-class, convenient, and clinically robust sleep apnea diagnostic solution that can be completed entirely at home. Obstructive sleep apnea (OSA) affects more...

AUSTIN, Texas--(BUSINESS WIRE)--IntraBio Inc., a global biopharmaceutical company focused on developing and commercializing therapies for neurological diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for AQNEURSA® (levacetylleucine) for the treatment of Ataxia-Telangiectasia (A-T) in adults and pediatric patients. The FDA simultaneously granted Priority Review and assigned a PDUFA target action date o...

LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it will present at the Goldman Sachs 47th Annual Global Healthcare Conference in Miami Beach, Fla. Vladimir Makatsaria, Chief Executive Officer of LivaNova; Alex Shvartsburg, Chief Financial Officer; and Phil Kowalczyk, Chief Strategy and Corporate Development Officer, will participate in a fireside chat on Mon., June 8, 2026, at 8 a.m. Eastern Daylight Time. The discussion will be...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced promising results from preclinical in vitro experiments evaluating the risk for phototoxicity, which indicated no photoreactive potential for EB-003, further derisking its continued development for the chronic treatment of neuropsychiatric disorde...

ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today announced that the company has entered into a clinical development collaboration with Merck, known as MSD outside of the United States and Canada, to supply KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in combination with zanzalintinib in STELLAR-316, a planned phase 3 pivotal trial in patients with resected stage II/III colorectal cancer (CRC). Under the terms of th...

DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage, AI-driven precision oncology company, today announced that it has received a successful response to its recent Type C meeting request from the U.S. Food and Drug Administration (FDA), focused on the ongoing Phase 2 HARMONIC™ trial of LP-300 in never-smokers with advanced non-small cell lung cancer (NSCLC) adenocarcinoma. In its written responses to Lantern's Type C meeting request, the FDA raised no objections to key...

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer: WHAT’S HAPPENING Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review designation for its investigational oral Factor XIa (FXIa) inhibitor, asundexian, for the prevention of secondary stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). The NDA is based on positive results from the global, pivotal Phase III OC...

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the New England Journal of Medicine has published the full results of its TETON-1 study, as well as combined analyses of its TETON-1 and TETON-2 studies, evaluating the use of nebulized Tyvaso for the treatment of IPF. The publication is available here. A summary of the publication was also presented today during a symposium at th...