FDA

STRATA Skin Sciences Announced That the Ministry of Health, Labor and Welfare Approved the XTRAC Momentum™ 1.0 Device in Japan, Specifically Designed to Treat Inflammatory Skin Conditions On July 22, 2024, STRATA Skin Sciences, Inc., a medical technology company specializing in developing, commercializing, and m...

Inspira™ Secured Approval From Israeli Authorities for its INSPIRA™ ART100 System On July 11, 2024, Inspira™ Technologies OXY B.H.N. Ltd., a pioneering medical technology company, secured a pivotal milestone with the receipt of the Israeli Ministry of Health's medical devices and accessories ("AMAR") approval fo...

Immutep Announces Promising Outcomes for First-Line Treatment in PD-L1 Negative Head and Neck Squamous Cell Carcinoma Patients Immutep Limited announced positive results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, evaluating eftilagimod alfa (efti) combined with MSD’s anti-PD-1 therapy KEYTR...

Lilly Strengthens IBD Treatment Portfolio with Morphic Acquisition Eli Lilly and Company and Morphic Holding, Inc. announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for serious chronic diseases. Lilly will initiate a tender offer to acqu...

Eisai Announces Solo Venture for Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate Eisai Co., Ltd. announced the termination of its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC), previously known as MORAb-202, an ...

Alcon's Newest Technological Marvels, Unity VCS, and Unity CS, Achieved 510(k) Clearance From the U.S. FDA, Paving the Way for New Advancements  On June 24, 2024, Alcon, the foremost name in eye care with a mission to help people see brilliantly, revealed that the U.S. Food and Drug Administration (FDA) had...

Alnylam's HELIOS-B Phase III Study of Vutrisiran Shows Positive Results, Meeting All Primary and Secondary Endpoints Alnylam Pharmaceuticals, Inc. reported encouraging topline outcomes from its HELIOS-B Phase III study of vutrisiran, an experimental RNAi therapy being developed to treat ATTR amyloidosis with car...

Boston Scientific Corporation Announced Definitive Agreement to Acquire Silk Road Medical, Inc., an Innovator in Stroke Prevention Technology On June 18, 2024, Boston Scientific Corporation, a global leader in medical technologies, announced the formal agreement to acquire Silk Medical, Inc., a medical device co...

Takeda Reveals Phase III Results for Soticlestat (TAK-935) in Dravet and Lennox-Gastaut Syndromes Takeda revealed topline results from its SKYLINE and SKYWAY studies. SKYLINE (TAK-935-3001) was a multicenter, randomized, double-blind Phase III trial assessing soticlestat (TAK-935) plus standard care against plac...

Moderna Reports Successful Phase III Trials for Dual Influenza and COVID-19 Vaccine Moderna, Inc. has reported that its Phase III trial for mRNA-1083, an experimental combination vaccine targeting both influenza and COVID-19, achieved its main objectives by generating a stronger immune response than the approved...