Merck INc., announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and… read more.
Alnylam Pharmaceuticals, Inc. announced that the FDA has granted Fast Track designation to vutrisiran, an investigational therapeutic for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis… read more.
AstraZeneca will initiate a randomised, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19… read more.
BeiGene, Ltd. a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the Phase III trial evaluating… read more.
AstraZeneca and Merck Inc.announced that the FDA has approved the kinase inhibitor Koselugo (selumetinib) for the treatment of paediatric patients two years of age and older with neurofibromatosis… read more.
Menlo Therapeutics Inc. announced top line results from two Phase III clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus… read more.
Gilead Sciences, Inc. announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an… read more.
Immunomedics, Inc. has announced that its Phase III confirmatory ASCENT study will be halted due to compelling evidence of efficacy. This decision was based on the unanimous recommendation… read more.
-Merck Inc., has announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy. The application… read more.
Adial Pharmaceuticals, Inc. provided an update on its landmark ONWARD Phase III pivotal trial of its lead drug candidate, AD 04 in genetically identified subjects for the treatment… read more.
Genentech, a member of the Roche Group announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug… read more.
-Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab), administered concomitantly with a limited course of… read more.
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