Sustol Gets FDA Approval for Extended Release August 16, 2016 The drug is approved for use in the prevention of nausea and vomiting related to chemotherapy. Read More
Merck Nets Third FDA Approval for Keytruda as Cancer Treatment August 12, 2016 FDA approval covers a 200-mg fixed dose every three weeks. Read More
AZ Fizzles in Phase 3 Trial for Cancer Drug Selumetinib August 12, 2016 The drug did not meet its primary endpoint of progression-free survival. Read More
FDA Gives Green Light to First Generic Version of Tamiflu August 11, 2016 The drug is widely used to fend off the flu and treat flu symptoms. Read More
FDA Approves AbbVie’s Viekira XR August 11, 2016 The FDA has granted approval to AbbVie’s Viekira XR for patients with hepatitis C virus. Read More
NICE Nixes Therapy Used to Treat Hodgkin’s Lymphoma August 10, 2016 The UK’s drug pricing watchdog is recommending that the National Health Service not reimburse for Takeda’s lymphoma drug Adcetris. Read More
Sustol Receives FDA Approval for Extended Release August 10, 2016 The FDA has approved an extended release-version of Heron Therapeutics’ nausea drug Sustol. Read More
Cardiome Gets EMA Approval for Xydalba Indication August 10, 2016 Drug is approved for acute bacterial skin and skin structure infections in adults. Read More
EMA’s Adaptive Pathway Pilot Hits Benchmark, Moves to Formalization August 9, 2016 New path allows real world evidence to supplement randomized clinical trials. Read More
FDA Writes Up CRL to ADMA Biologics Over Inspection Findings August 5, 2016 The agency pointed to problems with three contract manufacturers hired by ADMA. Read More
FDA Approves Novartis’s Breast Cancer Drug for Breakthrough Designation August 4, 2016 The designation drug candidate is for use in combination with letrozole. Read More
Agilis’s AGIL-FA Gets Orphan Drug Designation August 4, 2016 Agilis says it’s the first company to receive orphan drug designation for a gene therapy. Read More