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RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. KEYTRUDA QLEX must be administer...

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR) announced today that it will host a webcast to review data from the successful TETON-2 pivotal study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic pulmonary fibrosis (IPF) on Sunday, September 28, 2025, at 12:30 p.m. Eastern Time. During the webcast, Steven D. Nathan, M.D., Schar Chair, Advanced Lung Disease and Lung Tran...

WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Announces Additional FDA Approval of Opzelura® (Ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis...

DENVER & MAHWAH, N.J.--(BUSINESS WIRE)--ForCast Orthopedics, Inc. and KORU Medical Systems, Inc. (NASDAQ: KRMD) today jointly announced an agreement leveraging KORU Medical’s FreedomEDGE® infusion system as part of ForCast’s technology platform for the treatment of periprosthetic joint infection (PJI). PJI is a rare but serious complication of joint replacement procedures, and is challenging to treat because the infecting bacteria adhere to the prothesis and can form a protective biofilm which...

CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Pharma's Unidose Liquid System delivers FDA-approved Enbumyst™ (Bumetanide Nasal Spray) 0.5mg by Corstasis Therapeutics....

SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. today announced it has rebranded as Genetix Biotherapeutics Inc., returning to its foundational roots. Genetix, now strengthened both financially and operationally, is significantly better positioned to harness its decades of scientific innovation and extensive clinical data from hundreds of treated patients to more effectively deliver life-changing genetic therapies. The recently appointed Genetix management team, led by CEO David Meek, is...

CHICAGO--(BUSINESS WIRE)--Brainlab announced FDA 510(k) clearance and US launch for Spine Mixed Reality Navigation, a milestone in the advancement of spinal surgery....

LIESTAL, Zwitserland--(BUSINESS WIRE)--Curatis Holding AG (SIX:CURN) heeft de officiële notulen ontvangen van de FDA-vergadering die op 9 september plaatsvond. Op basis van de volledige feedback en de besproken punten kan Curatis doorgaan zoals gepland met de klinische ontwikkeling van corticorelin. Corticorelin wordt ontwikkeld als een innovatieve behandeling die het gebruik van steroïden en de bijbehorende toxiciteiten kan verminderen of zelfs elimineren, en zo mogelijk de kwaliteit van leven...

WILMINGTON, Del.--(BUSINESS WIRE)--AIRSUPRA’s US Prescribing Information now includes clinically meaningful evidence from the BATURA study in patients with mild asthma.1 The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed AIRSUPRA compared to as-needed albuterol,2 the most commonly used rescue medication for asthma in the US. The BATURA trial demonstrated treatment with AIRSUPRA significantly reduced the risk of a severe exacerbati...

SALT LAKE CITY--(BUSINESS WIRE)--iVeena Delivery Systems, Inc. (“iVeena”), a clinical-stage ophthalmology company, today announced it has been awarded a $2 million Phase 2 Small Business Innovation Research (SBIR) grant from the National Eye Institute (NEI) of the National Institutes of Health (NIH). The funding will advance the development of novel topical eye drops being investigated to control pediatric myopia and other refractive disorders. iVeena’s research is led by Sarah Molokhia, PhD, V...