Merck’s STRIDE-8 phase 3 trial of Capvaxive demonstrates positive ...
1 day ago · Merck, known as MSD outside of the United States and Canada, announced results from STRIDE-8, a phase 3 trial evaluating Capvaxive (Pneumococcal 21-valent Conjugate Vaccine), at IDWeek 2024 in Los Angeles, California. The trial evaluated the immunogenicity, safety and tolerability of Capvaxive ...
Cullinan Therapeutics gets US FDA clearance to proceed phase 1 …
22 hours ago · Cullinan Therapeutics, Inc., a biopharmaceutical company focused on developing modality-agnostic targeted therapies, announced that the US Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) Application for CLN-978 and its global phase 1 clinical trial may ...
Annovis Bio gets US FDA clearance to begin pivotal phase 3 …
21 hours ago · Malvern headquartered Annovis Bio Inc, a late-stage clinical drug platform company developing transformative therapies for neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease, announced the successful outcome of the end-of-phase 2 meeting with the US Food and Drug ...
Hoth Therapeutics receives US patent for its pioneering …
1 day ago · Thursday, October 17, 2024, 11:00 Hrs [IST] Hoth Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing innovative treatments, is proud to announce the granting of a US patent for its pioneering Alzheimer's treatment, HT-ALZ. This milestone patent secures the company's intellectual property rights to its novel ...
Pfizer’s Hympavzi receives US FDA approval to treat adults and ...
4 days ago · Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and paediatric patients 12 years of age and older with haemophilia A (congenital factor VIII ...
Pfizer, BioNTech receive US FDA approval & authorization for …
Saturday, August 24, 2024, 09:00 Hrs [IST] Pfizer Inc. and BioNTech SE announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (Covid-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 ...
US FDA approves Roche’s Ocrevus Zunovo to treat relapsing …
Basel. Tuesday, September 17, 2024, 10:00 Hrs [IST] Roche announced that the United States Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus Zunovo is the first and only twice-a-year ...
Novo Nordisk’ Wegovy gets US FDA approval for cardiovascular …
Mar 11, 2024 · Novo Nordisk’ Wegovy gets US FDA approval for cardiovascular risk reduction in people with overweight or obesity and established CVD: Bagsværd, Denmark
Boehringer Ingelheim’s Cyltezo to treat multiple chronic …
Friday, May 3, 2024, 11:00 Hrs [IST] Boehringer Ingelheim Group, one of the largest producers of biologic medicines in the world, announced that the US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), the company's interchangeable biosimilar to Humira (adalimumab), to ...
US FDA grants Priority Review status Novartis’ Scemblix for …
Jul 31, 2024 · US FDA grants Priority Review status Novartis’ Scemblix for treatment of adults with newly diagnosed CML: East Hanover Wednesday, July 31, 2024, 12:00 Hrs [IST]