Browsing items tagged “FDA | EVERSANA”

FDA Approves Roche, PTC’s SMA Treatment, Evrysdi (Risdiplam)

Region: NORTH AMERICA | Type: Drug Approval | Keywords: #evrysdi #fasttrackdesignation #fda #orphandrug #pdufa #pediatrics #priorityreview #ptc #risdiplam #roche #sma PRICENTRIC BRIEF: The Food and Drug Administration (FDA) has approved Roche and PTC Therapeutics’ Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA) in adults and children aged 2 months and up In FIREFISH and SUNFISH, two clinical trials containing more than 450 patients with varying ages and levels of […]

FDA Approves BMS’ Opdivo for Advanced ESCC After Chemotherapy

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #bms #escc #esophagealcancer #fda #priorityreview PRICENTRIC BRIEF: The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), following prior fluoropyrimidine- and platinum-based chemotherapy Approval from the U.S. regulator is based on results from […]

FDA Sets September Review Date for Novartis’ Multiple Sclerosis Targeted B-Cell Therapy, Ofatumumab

Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #actionadate #b-celltherapy #fda #multiplesclerosis #novartis #ofatumumab #sbla PRICENTRIC BRIEF: The U.S. Food and Drug Administration (FDA) issued a notice to Swiss-based Novartis explaining that the agency has extended its review of the supplemental Biologics License Application (sBLA) for ofatumumab, a targeted B-cell therapy for relapsing multiple sclerosis (MS) The FDA is now expected to make a decision […]

FDA Grants Enhertu Orphan Drug Designation for Gastric Cancer

Region: NORTH AMERICA | Type: Regulation | Keywords: #astrazeneca #daiichisankyo #deruxtecan #enhertu #orphan #trastuzumab PRICENTRIC BRIEF: The FDA has granted Orphan Drug Designation to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of patients with gastric cancer, including gastroesophageal junction cancer The designation was supported by data from the Phase II DESTINY-Gastric01 trial, in which Enhertu demonstrated a statistically significant and clinically meaningful improvement in objective response […]

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 […]

FDA Publishes Final Rule on New Regulatory Pathway Shift for Insulin, Other Biologics

Country: UNITED STATES | Region: NORTH AMERICA | Type: Policy | Keywords: #biologicdrugs #biosimilar #fda #insulin #regulation PRICENTRIC BRIEF: On March 23, 2020, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulin and other biological products, will be deemed to be a license for the product under the Public Health Service (PHS) Act For the first […]

FDA Releases Guidance on Gene Therapy Manufacturing, Clinical Development

Country: UNITED STATES | Region: NORTH AMERICA | Type: Policy | Keywords: #clinicaldevelopment #fda #genetherapy #guidance PRICENTRIC BRIEF: The Food and Drug Administration has approved 4 gene therapy products thus far, and anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area To support the continued development of gene therapies, […]