FDA Authorizes First Point-of-Care Antibody Test for COVID-19
September 23, 2020: "The U.S.FDA issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.
BMS Opdivo shows benefit in Gastric and Esophageal Cancers
September 21, 2020: "Bristol Myers Squibb announced primary results from CheckMate -649, the pivotal Phase 3 trial in which first-line treatment with Opdivo (nivolumab) plus chemotherapy...
Sanofi and GSK sign agreements with Canada to supply up to 72 million doses of COVID-19 vaccine
September 22, 2020: "Sanofi and GSK have signed agreements with the Government of Canada for the supply of up to 72 million...
Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program
September 23, 2020: "Novartis Gene Therapies recently received feedback from the US Food and Drug Administration (FDA) following their review of data from...
Sanofi’s Supemtek® approved for the prevention of influenza in adults
September 22, 2020: "The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Supemtek®...
KEYTRUDA® Plus LENVIMA® shows promise in hard-to-treat cancers
September 20, 2020: "Merck and Eisai announced new investigational data from two trials under the LEAP (LEnvatinib And Pembrolizumab) clinical program evaluating...
FDA Announces Key FSMA Rule to Advance Traceability of Foods
September 21, 2020: "The FDA has proposed a new rule that lays the foundation for the end-to-end food traceability across the food industry that...
Novartis Kisqali® receives the highest rating of any CDK4/6 inhibitor
September 21, 2020: "Novartis proudly announces that Kisqali® (ribociclib) has achieved a score of five out of five on the European Society for...
AstraZeneca’s Lynparza recommended for metastatic castration-resistant prostate cancer
September 21, 2020: "AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the EU for patients with metastatic castration-resistant prostate cancer...
Coronavirus (COVID-19) Update: Daily Roundup September 18, 2020
September 18, 2020: "The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
AstraZeneca’s Tagrisso reduced risk of disease recurrence in brain in EGFR-mutated lung cancer
September 19, 2020: "Results from a prespecified exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a clinically meaningful...
GSK receives CHMP approval of Zejula for the treatment of ovarian cancer
September 18, 2020: "GlaxoSmithKline announced the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion...
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AZ’s Tagrisso scores priority review from FDA with EGFR-mutated lung cancer
October 20, 2020: "AstraZeneca’s Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in...
Forxiga recommended for approval in the EU by CHMP for heart failure
October 19, 2020: "AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the...
AstraZeneca advances leadership in renal disease at ASN Kidney Week 2020 Reimagined
October 20, 2020: AstraZeneca will present 84 abstracts, including 12 oral presentations and three late-breaking abstracts, across its industry-leading renal portfolio which...
AbbVie’s VENCLEXTA® Receives FDA Approval for Acute Myeloid Leukemia
October 16, 2020: "AbbVie announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA® (venetoclax) in combination...
