approval

COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue ApS today announced CE Mark approval for the NEURESCUE® device, the first and only medical device approved to treat non-shockable cardiac arrest. Granted by TÜV SÜD after an expedited six-month review under Europe’s Medical Device Regulation (MDR), this milestone marks one of the most significant advances in resuscitation since the introduction of CPR in 1960. An estimated 81% of all cardiac arrest patients present as non-shockable, making them in

BLUE BELL, Pa.--(BUSINESS WIRE)--inTRAvent Medical wins FDA clearance for next-gen SOLOPASS® 2.0 neurosurgical navigation system

(NYSE:VAR) PALO ALTO, Calif.--(BUSINESS WIRE)--Varian, a Siemens Healthineers company, announced today that its Embozene microspheres have received CE Marking for Genicular Artery Embolisation (GAE) for knee osteoarthritis. This regulatory milestone makes Embozene the first—and only—embolic agent to be CE Marked specifically for GAE, a minimally invasive procedure intended to target inflammation and help relieve pain in patients with knee osteoarthritis. Knee osteoarthritis is widespread, with a reported

(NYSE:ROG) The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU. The VENTANA HER2 (4B5) test is also now approved to help identify patients with...

(NYSE:ROG) The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU. The VENTANA HER2 (4B5) test is also now approved to help identify patients with...

CAROL STREAM, Ill., Sept. 4, 2025 /PRNewswire/ -- Reliance Specialty Products, Inc., a leader in comprehensive vapor degreasing solutions, announces that two of its newest solvents: AeroTron-AV-5408 and AeroTron-GS-5408 have been officially approved by Boeing for use under the BAC 5408...

TEL AVIV, Israel--(BUSINESS WIRE)--Fairtility, a global leader in transparent AI for reproductive care, today announced that its CHLOE platform has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for one of its AI-powered embryo assessment tools, CHLOE Blast™, making it the first and only FDA-cleared machine learning AI-powered clinical decision support software for embryo assessment. The embryo assessment function of CHLOE analyzes time-lapse embryo images to enable more obje

(NYSE:MDT) GALWAY, Ireland, Sept. 2, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced two U.S. Food and Drug Administration (FDA) regulatory milestones that broaden the MiniMed™ 780G system portfolio: clearance of the SmartGuard™ algorithm as...

If approved, obicetrapib, licensed from NewAmsterdam Pharma, would be the first CETP inhibitor to be available, as an adjunct to diet, for patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and unable to reach low-density...

(NASDAQ:ZLAB) SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. “Today’s approval of TIVDAK marks an important milestone for Zai Lab, further strengthening our Women’s franchise in Greater China,” said Andrew Zhu, Chief Commercial Of

(NASDAQ:BIIB) Subcutaneous delivery increases accessibility and introduces potential for at-home administration, following model of diabetes and GLP-1 drugs NEW YORK, Aug. 29, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced its approval of a subcutaneous formulation of...

(NASDAQ:BIOA) STOCKHOLM, Aug. 29, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA-B) partner Eisai announced today the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab subcutaneous injection for maintenance dosing....

(NASDAQ:BIIB) LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months

LUND, Sweden, Aug. 28, 2025 /PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Oczyesa®, octreotide subcutaneous depot, marketing authorization for the maintenance treatment in adult patients with...

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts the

NEW YORK and MAINZ, GERMANY, AUGUST 27, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.2

SHENYANG, China, Aug. 27, 2025 /PRNewswire/ -- Neusoft Medical Systems today announced that its NeuViz P10 photon-counting CT has received market approval from China's National Medical Products Administration (NMPA). This marks the first photon‑counting CT approved in China, and the...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted marketing authorization for Yeytuo® (lenacapavir)—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg. Yeytuo is the first and only twice-yearly PrEP option to be approved for

Bevacizumab Injection officially approved by Indonesia's National Agency of Drug and Food Control (BPOM), following Nigeria, Pakistan, and Colombia – accelerating global commercialization Approval in ASEAN's largest pharma market strengthens BioDlink's position as a global supplier of...

REYKJAVIK, ICELAND and LONDON, UK (August 21, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission has approved Mynzepli® as a biosimilar to Eylea® (aflibercept), in a pre-filled syringe and vial.