Browsing items tagged “drug approval | EVERSANA”

Deciphera’s Qinlock Approved for Fourth-Line GIST Treatment by FDA

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #deciphera #fda #projectorbis #qinlock #realtimeoncologyreview PRICENTRIC BRIEF: The Food and Drug Administration (FDA) approved Deciphera’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib (branded as “Gleevec” by Novartis in the U.S.) The New Drug Application (NDA) […]

FDA OK’s AZ & Merck’s Lynparza Plus Bevacizumab in HRD-Positive Ovarian Cancer

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #astrazeneca #fda #merck PRICENTRIC BRIEF: Lynparza (olaparib) in combination with bevacizumab (branded as Avastin) was approved by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and […]

FDA Grants Priority Review to Merck’s Keytruda, Use Based on Biomarker Regardless of Tumor Type

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #biomarker #fda #immunotherapy #merck #priorityreview PRICENTRIC BRIEF: The application is for Merck’s Keytruda (pembrolizumab) as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) greater than or equal to 10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment […]

South Korea Agrees to Numerous Arrangements with European Counterparts

Country: FRANCE, SOUTH KOREA, SWITZERLAND | Region: ASIA & SOUTH PACIFIC, EUROPE | Type: Regulation | Keywords: #ansm #drugapproval #europeandirectorate #gmpinspection #swissmedic PRICENTRIC BRIEF: The Ministry of Food and Drug Safety agreed to a joint trust arrangement for good manufacturing practice (GMP) with the Swiss Agency for Therapeutic Products, Swissmedic, a deal that will lessen the drug approval procedure for local biopharmaceutical firms by excusing them from Swiss GMP assessment Moreover, […]