FDA Grants Priority Review for Bristol-Myers Squibb’s Opdivo in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer April 11, 2017 The FDA action date is Aug. 2, 2017. Read More
Regeneron’s Evinacumab Receives Breakthrough Therapy Designation by the FDA April 11, 2017 Regeneron is planning to conduct a Phase III trial, but did not provide a timeline. Read More
FDA Grants Fast Track Designation to Innocrin Pharmaceuticals’ Seviteronel April 10, 2017 Seviteronel is a once-daily oral therapeutic given without prednisone. Read More
FDA Expands Harvoni, Sovaldi Hep C Treatments to include Children over 12 April 10, 2017 The Harvoni approval was based in part on an open-label, multicenter clinical trial that included 100 pediatric patients. Read More
FDA Rejects Merck’s Request to Add Cardiovascular Safety Data to Januvia’s Label April 7, 2017 The FDA rejected Merck’s bid to add cardiovascular safety data to its oral diabetes medication Januvia and its combinations. Read More
Indian Authority Provides Marketing Clearance to APAC Biotech’s Apceden April 7, 2017 The drug contains a tumor antigen that can generate an effective immune response. Read More
FDA Agrees to Abridged Phase III Trial for Wockhardt Antibiotic April 7, 2017 WCK 5222 is a combination of cefepime and zidebactam, a new drug developed by Wockhardt. Read More
March Sees New Surge of Nearly 200 Submitted ANDAs April 6, 2017 The FDA received a fresh wave of ANDAs in March, nearly doubling the total amount from the first two months of the year. Read More
FDA Converts Tagrisso to Full Approval in NSCLC after Confirmatory Phase III Trial April 6, 2017 Tagrisso had also received Fast Track, Breakthrough Therapy and Priority Review from the FDA. Read More
FDA Accepts Novartis, Kite Pharma’s Personalized Cancer Treatments for Review April 6, 2017 Nearly half of the patients in the trial experienced grade 3 or 4 cytokine release syndrome. Read More
ANDA Applications Could Hit New Record in Fiscal 2017 April 6, 2017 Fiscal 2016 saw 852 applications total, while December 2016 alone brought in 235. Read More
FDA Approves Roche’s Ocrevus for Relapsing and Primary Progressive MS April 4, 2017 Ocrevus demonstrated superior efficacy on the three major markers of disease activity. Read More