FDA

View All

medtech-news-for-inspira-oticon-medical-spineguard
Inspira™ Approval of INSPIRA™ ART100 System; Oticon Medical’s Sentio™ System Received Regulatory Clearance; SpineGuard Filed its “510K” Dossier in the US; Vectorious Medical Technologies’ V-LAP Left Atrial Pressure Sensor Successful Implantation; Bedal International Raised $11 Million; Mytonomy Inc. Agreement With Vizient, Inc.

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...

Find More

pharma-news-immutep-pfizer-novo-nordisk-arcutis
Immutep’ First-Line Treatment Positive Outcomes; Pfizer’s Once-Daily Oral GLP-1 Agonist Danuglipron; FDA Issues Complete Response Letter to Novo Nordisk; Arcutis’ ZORYVE® Cream 0.15% FDA Approval; NICE Recommends Ebglyss For Moderate To Severe Atopic Dermatitis

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...

Find More

pharma-news-for-eli-lilly-ideaya-roche-sanofi
Lilly’s Morphic Acquisition; IDEAYA’s IDE397 Positive Phase II Trial Result; XPOVIO (selinexor) Approval in China; Roche to Reintroduce Susvimo in the US; Dupixent EU Approval

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...

Find More

pharma-news-for-eisai-merck-verona-astrazeneca
Eisai Announces Solo Development of Farletuzumab Ecteribulin (FZEC); Johnson & Johnson’s Nipocalimab Phase III Trial; Merck’s WINREVAIR  EU CHMP Recommendation;  Verona Pharma’s  Ohtuvayre FDA Approval; AstraZeneca’s Lynparza and Imfinzi EU Approval

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 ...

Find More

medtech-news-for-alcon-globus-medical-ricoh-esaote
Alcon’s 510(k) Clearance From the FDA; Globus Medical Received FDA Clearance; UK Pioneers First Skull-Mounted Epilepsy Device for Child; The Initiation of a Significant Clinical Trial of 3d Printed Models; Esaote Unveiled the Cutting-Edge Mylab™E80 @Sirm Ultrasound Device For 2024; Medasense Unveiled a Transformative Partnership With Nihon Kohden Corporation

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...

Find More

pharma-news-for-alnylam-bms-daichii-sankyo-vertex
Alnylam’s HELIOS-B Phase III Study of Vutrisiran; Bristol Myers Squibb Secures FDA Nod for KRAZATI and Cetuximab; Daichii Sankyo’s EZHARMIA® Receives Japan Approval; Vertex’s Phase I/II VX-880 Trial; argenx’s VYVGART Hytrulo FDA Approval

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...

Find More

medtech-news-for-boston-scientific-corporation-philips-akili-roche
Boston Scientific Corporation Agreement to Acquire Silk Road Medical; Philips Introduced Duo Venous Stent System; Akili’s EndeavorOTC Received FDA Clearance; Roche Achieved FDA Clearance; atHeart Medical Reported Long and Short-term Clinical Data; Bioretec Announced Successful Clinical Outcomes

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...

Find More

pharma-news-for-takeda-astrazeneca-johnson-and-johnson-bms
Takeda Showcase Phase III Results for Soticlestat; Imfinzi and Chemotherapy Combination Gains US Approval; Nipocalimab Shows Notable Efficacy in Phase II Study; Bristol Myers Squibb’s Augtyro FDA Approval; AstraZeneca’s Farxiga FDA Approval

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...

Find More

pharma-news-for-moderna-almirall-lilly-ipsen
Moderna’s Phase III Trials for Dual Influenza and COVID-19 Vaccine; Almirall’s Klisyri FDA Approval; Lilly’s Tirzepatide MASH Trial; Cycle Pharmaceuticals Acquisition of Vanda Pharmaceuticals; Ipsen’s Iqirvo FDA Approval

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...

Find More

medtech-news-for-stryker-qiagen-evolution-optiks-nexalin
Stryker’s LIFEPAK 35 Monitor/Defibrillator; Qiagen’s QIAstat-Dx Respiratory Panel; Evolution Optiks’s 510(k) Clearance; Microbot Medical Endovascular Surgical Robot Trial; Nexalin’s Insomnia and Anxiety Therapy Headset Clinical Trial; KORU Medical Systems’ Study With Commercialized Oncology Biologics

Stryker Released LIFEPAK 35 Monitor/Defibrillator  On June 04, 2024, Stryker, a global leader in medical technologies, announced the launch of the LIFEPAK 35 monitor/defibrillator. This latest addition to their monitor/defibrillator lineup features advanced technology and is designed on an intuitive, modern...

Find More