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.
Pfizer Inc.announced that the FDA has approved Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) for the treatment of adult patients with metastatic colorectal cancer (CRC) with… read more.
Alnylam Pharmaceuticals, Inc. announced the completion of the rolling submission of a New Drug Application (NDA) to the FDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase… read more.
Mallinckrodt Plc has announced that Stratatech, a Mallinckrodt company, has initiated the rolling submission of a Biologics License Application (BLA) to the FDA seeking approval to market StrataGraft,… read more.
Mateon Therapeutics, Inc.dedicated to development OT101, a TGF-beta antisense drug candidate, announced that Mateon has delivered the requisite testing results to Golden Mountain Partners (GMP) confirming the applicability… read more.
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