regulatory

MONTPELLIER, France--(BUSINESS WIRE)-- #fda--Womed®, the uterine health company developing innovative intrauterine treatments to free women from uterine pathologies, today announced that the Food and Drug Administration approved the PreMarket Approval (PMA) application of the Womed Leaf® for adult women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions, also referred to as Asherman syndrome. Womed Leaf® is the first medical device to be approved for sale in the

ST. PETERSBURG, Fla.--(BUSINESS WIRE)-- #security--Xonar Technology receives QATT designation from U.S. Department of Homeland Security for TruePort security screening device.

HENDERSON, Nev.--(BUSINESS WIRE)-- #CHF--Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, today announced that the U.S. Food and Drug Administration (FDA) has approved ENBUMYST™ (bumetanide nasal spray). ENBUMYST is indicated for the treatment of edema associated with congestive heart failure (CHF), and hepatic and renal disease, including nephrotic syndrome in adults. Addressing a

LITTLETON, Mass.--(BUSINESS WIRE)-- #MevionFIT--Mevion Medical Systems today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the MEVION S250-FIT™ Proton Beam Radiation Therapy System, marking a significant milestone in expanding access to proton therapy.  The MEVION S250-FIT is the first and only proton therapy system designed to seamlessly fit into a standard radiation therapy vault. By leveraging existing infrastructure, the MEVION S250-FIT system lowers barrier

(NASDAQ:AZN) BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)--Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab. Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6 directed DXd antibody drug conjugate

The prodisc® C Vivo and prodisc® C Nova Cervical Total Disc Replacement (TDR) devices are now certified and CE-marked in accordance with the EU Medical Device Regulation (MDR) – the highest European standard of quality, safety, and performance for medical devices. The prodisc C Vivo and...

LONDON, Sept. 11, 2025 /PRNewswire/ -- Naitive Technologies, a medical technology company developing AI-driven software to reimagine orthopedic care, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its flagship product, OsteoSight....

FORM 8.5 (EPT/RI)

SEATTLE--(BUSINESS WIRE)--AGC Biologics announced that its Seattle manufacturing facility achieved operational excellence milestones in 2025.

(NASDAQ:TIVC) FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced that it has completed verification of its Entolimod™ cell line, the first step in establishing Current Good Manufacturing Practices (CGMP) in preparation for a Biologics License Application, or BLA. Cell line verification in recombinant protein production is required because it ensures the processes used to grow cells and activate protein expression do not comp

(NASDAQ:CORT) REDWOOD CITY, Calif.--(BUSINESS WIRE)--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the U.S. Food and Drug Administration (FDA) has accepted Corcept’s New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer

(NASDAQ:TNDM) SAN DIEGO--(BUSINESS WIRE)---- $TNDM #diabetes--Tandem t:slim Mobile App authorized by Health Canada for iPhone and Android Phones. The app will be available for Canadian customers later this year.

In this free webinar, learn why demonstrating clonality is critical to gene therapy manufacturing and how image-based documentation supports regulatory compliance. Attendees will learn how static culture conditions impact single-cell cloning in HEK293 lines adapted for suspension. The...

(SH600298) SHANGHAI, Sept. 4, 2025 /PRNewswire/ -- Angel Yeast (SH600298), a leading global provider of yeast and fermentation-based ingredients, announced today that its proprietary yeast protein, AngeoPro, has been granted Generally Recognized as Safe (GRAS) status by the U.S. Food and Drug...

(NASDAQ:AQST) WARREN, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that an advisory committee meeting is not required for Anaphylm™ (dibutepinephrine) Sublingual Film. The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm remains January 31, 2026.

The LuMon™ System is also CE-marked under EU MDR and registered with TGA in Australia. LINCOLN, R.I., Sept. 4, 2025 /PRNewswire/ -- Sentec, a global leader in non-invasive patient monitoring, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for...

(NASDAQ:AGIO) Agios announced that the U.S. FDA has extended the PDUFA goal date for the sNDA of PYRUKYND for adults with thalassemia by three months to December 7, 2025

(NASDAQ:ARCT) Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% to Expand Indication for Treatment of Plaque Psoriasis in Children

Breakthrough Therapy Designation is based on results from the Beamion-LUNG 1 clinical trial evaluating HERNEXEOS® (zongertinib tablets) as a first-line treatment in HER2 (ERBB2)-mutant advanced NSCLC Follows recent accelerated approval of HERNEXEOS for previously treated patients with...

SOUTHLAKE, Texas & MARSEILLE, France--(BUSINESS WIRE)-- #COMANECI--Clinical success and MDR approval position DRIVEWIRE™ 24 as a next-generation access technology set to reshape neurovascular practice.