FDA News

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s ETCAMAH® (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib, palbociclib or ribociclib) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor (AI) and CDK4/6 inhibitor therapy, based on a US Food and Drug Administration (FDA)-authorized test...

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) to identify patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer harboring tumors with ESR1 mutations before radiographic progression who may benefit from treatment with ETCAMAH™ (camizestrant), AstraZeneca’s next-gener...

CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM) today announced that Founder and CEO Eric Lefkofsky will participate in a fireside chat at the Morgan Stanley 24th Annual Global Healthcare Conference on Tuesday, September 15, 2026, at 8:30 a.m. ET in New York City.A live audio webcast of the conversation will be available here.About TempusTempus AI is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of t...

BEDFORD, Mass. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, and Biogen Inc. (Nasdaq: BIIB) today announced presentations of data at the 16th European Epilepsy Congress (EEC), taking place September 5-9 in Athens, Greece. These data support the potential of zorevunersen as a first-in-class disease-modifying treatment for Dravet syndrome. Dravet...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--eGenesis Announces Clinical Update in Ongoing Expanded Access Study of EGEN-2784 in Patients with Kidney Failure...

ATLANTA--(BUSINESS WIRE)--Sequenex renews its ISO 13485:2016 certification for the design and development of software for use in medical devices....

BRENTWOOD, Tenn. & AUSTIN, Texas--(BUSINESS WIRE)--Heartvue.ai, a cardiac imaging AI company founded by cardiologists, and Innolitics, a medical device software and regulatory consultancy, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance (K260811) for Heartvue.Proton, Heartvue's machine learning–powered software for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance (MR) images. Innolitics guided Heartvue from initia...

CANTON, Ohio--(BUSINESS WIRE)--The Gabrail Cancer and Research Center, a PhaseWell Research site, today announced that Nashat Gabrail, M.D., has received notification from the U.S. Food and Drug Administration (FDA) that the investigator-initiated clinical trial may proceed under his Investigational New Drug (IND) application, evaluating STAR-LLD in combination with elranatamab in patients with relapsed or refractory multiple myeloma. T-cell engager therapies, including BCMA-directed bispecific...

MINNEAPOLIS--(BUSINESS WIRE)--DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia, fetal growth restriction and acute ischemic stroke, today announced that company management will participate in four upcoming investment bank conferences in New York. Details Citi Biopharma Back to School Summit September 9-10, 2026 Cantor Global Healthcare Conference September 9-11, 2026 Fireside Chat with Rick Pauls (CEO)...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced that the FDA has granted Fast Track and Orphan Drug designations to apitegromab for the treatment of people living with FSHD. In addition, the Company announced that participant dosing is underway in the Phase 2 FORGE c...