Blueprint Medicines announced that the FDA has issued a complete response letter (CRL) for the new drug application of Ayvakit (avapritinib) for the treatment of adults with unresectable… read more.
Bristol Myers Squibb announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the FDA for the first-line treatment of… read more.
Cassava Sciences, Inc. reported top-line results from a Phase IIb study of PTI 125, its lead investigational drug, in patients with Alzheimer’s disease. This study did not meet… read more.
ReGenTree, a U.S. joint venture company owned by GtreeBNT Co. and RegeneRx Biopharmaceuticals, announced the results of a randomized, double masked, placebo-controlled Phase III clinical trial (SEER-1) using… read more.
The FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab,… read more.
The FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab,… read more.
Pfizer Inc. announced top-line results from a second Phase 111 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots… read more.
Bristol Myers Squibb and bluebird bio, Inc. announced that the companies received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for idecabtagene… read more.
Vanda Pharmaceuticals Inc. announced that following the completion of a Type A Meeting with the FDA on 8 May 2020, it has reached agreement with the FDA to… read more.
Bristol Myers Squibb announced three-year follow-up results from Part 1 of the Phase III CheckMate -227 trial , demonstrating that Opdivo (nivolumab) plus Yervoy (ipilimumab) provided sustained improvements… read more.
Bristol Myers Squibb announced the first presentation of results from the Phase III CheckMate -9LA trial, which demonstrated a statistically significant and clinically meaningful survival benefit with Opdivo… read more.
Gamida Cell Ltd.:announced positive topline results from its Phase III clinical study evaluating the safety and efficacy of omidubicel, an investigational advanced cell therapy in development as a… read more.
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