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Refusal to File letter for idecabtagene vicleucel for patients with heavily pre-treated relapsed and refractory multiple myeloma. BMS + bluebird bio

Written by | 14 May 2020

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 agrees with the FDA on resubmission of the application for Hetlioz for the treatment of patients with Smith-Magenis syndrome.

Written by | 14 May 2020

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.

Three-year data from CheckMate -227 confirms durable, long-term survival benefit for Opdivo + Yervoy in metastatic first-line non-small cell lung cancer .- BMS

Written by | 14 May 2020

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.

Opdivo + Yervoy with limited chemotherapy significantly improves overall survival vs. chemotherapy alone for first-line metastatic non-small cell lung cancer in CheckMate -9LA study.- BMS

Written by | 14 May 2020

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.

Positive topline data from phase III study of omidubicel in patients with high-risk hematologic malignancies- Gamida Cell

Written by | 14 May 2020

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.

Health Canada approves first COVID-19 serological test for use in the country to detect COVID-19 antibodies. DiaSorin

Written by | 14 May 2020

Health Canada says it has authorized the first COVID-19 serological test for use in the country to detect antibodies specific to the virus. DiaSorin, an Italian multinational biotechnology… read more.

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