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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today new one-year data from the Phase III MEERKAT and SANDCAT studies evaluating investigational vamikibart compared with a sham procedure that mimics intravitreal (IVT) injections in adults with uveitic macular edema (UME). Across both studies, data continue to support the potential for rapid and sustained improvements in vision and reductions in macular thickness (swel...

TOKYO--(BUSINESS WIRE)--Asahi Kasei Therapeutics, Inc., the global specialty pharmaceutical business of Tokyo-based Asahi Kasei, with U.S. and European business headquarters in Cary, North Carolina, today announced that the U.S. Food and Drug Administration (FDA) has approved HOVILPRI® (pritelivir) 100 mg tablets for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection that is refractory (with or without documented resistance) to treatment with acyclovir, valacy...

WALTHAM, Mass.--(BUSINESS WIRE)--Affinia Therapeutics (“Affinia”), an innovative clinical-stage gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that AFTX-201 preclinical and translational data and the Phase 1/2 UPBEAT™ clinical trial investigating AFTX-201 in patients with BAG3-associated dilated cardiomyopathy (DCM), will be featured at the Heart Failure So...

MONTPELLIER, France--(BUSINESS WIRE)--Medincell (Paris:MEDCL) Medincell will host Investor webcast today to discuss the implications of the approval for the Company and answer questions from analysts.   Webcast Details Date: Friday, October 9, 2026 Time: 4:00 p.m. CEST / 10:00 a.m. ET Webcast: https://www.medincell.com/investor-webcast-oct-9-2026/ A replay of the webcast will be available on Medincell's website following the event. Medincell (Euronext: MEDCL) achieves major milestone with the a...

MAPLE GROVE, Minn.--(BUSINESS WIRE)--Urolution Medical, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OpenFlo® Urinary Catheter, marking a major milestone as the company advances toward clinical evaluation and commercialization. Cleared for urinary tract drainage in adult patients for indwell periods of up to 30 days, OpenFlo® incorporates a patented architecture that re-engineers key mechanical features of the conventional Foley cath...

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its multi-cancer early detection (MCED) assay has been granted Breakthrough Device designation (BDD) by the U.S. Food and Drug Administration (FDA). The BDD is designed for novel technologies that enable more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions. Natera’s MCED assay analyzes cell-free DNA in...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumor characterized by high mutation rates. This approval marks...

DENVER--(BUSINESS WIRE)--Cleerly, a leader in advanced cardiovascular imaging analysis, and Clear Heart and Lung Imaging, a leader in outpatient imaging care, have taken a cardiac-capable mobile CT scanner across the southern United States to expand access to cardiovascular research and enable communities and clinics to participate in Cleerly's TRANSFORM Trial. From July through September 2026, the CT scanner traveled through Arizona, Louisiana, Georgia, and Florida, bringing cardiovascular ima...

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced a partnership with actress and menopause advocate Melissa Joan Hart to increase awareness about Lynkuet® (elinzanetant) 60mg capsules, Bayer’s FDA-approved, hormone-free prescription treatment for moderate to severe hot flashes due to menopause.1 Through the partnership, Hart will share her personal experience with moderate to severe hot flashes due to menopause to help women recognize their symptoms and to encourage more proactive treatmen...

SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN® dual-masked T-cell engager (TCE), for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is being co-developed by Astellas Pharma Inc. and Vir Biotechnology through a global strategic collaboration. “Receiving Fast Track designation reflects the potent...