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FDA provide complete response letter for Ayvakit in fourth-line gastrointestinal stromal tumor.- Blueprint Medicines

Written by | 16 May 2020

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.

FDA approves Opdivo + Yervoy for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L.- BMS

Written by | 16 May 2020

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.

PTI 125 did not meet its primary endpoint in a phase IIb study for Alzheimer’s disease.- Cassava Sciences

Written by | 16 May 2020

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.

Phase III SEER-1 trial of RGN 259 shows efficacy in neurotrophic keratopathy.- ReGenTree + RegeneRx Biopharma

Written by | 16 May 2020

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.

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