FDA approval

FDA approves Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C infectionFDA approved EpclusaTM (sofosbuvir and velpatasvir, (SOF-VEL) for adults with chronic hepatitis C infection both with compensated cirrhosis or without cirrhosis as well as in combination with ribavirin for hepatitis C with decompensated cirrhosis.
Daclizumab approved for relapsing forms of multiple sclerosisDaclizumab is the first subcutaneous injectable monoclonal antibody to be approved for the treatment of MS.
First "artificial pancreas" for diabetes approved, plus 2 more FDA actionsFDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases. Here are the top 3 new approvals.
FDA approves first drug for Duchenne muscular dystrophyEven though an FDA panel recommended against approving a new drug to treat Duchenne muscular dystrophy in April, the agency granted accelerated approval to eteplirsen injection (Exondys 51, Sarepta Therapeutics) in mid-September.
New dosage form for migraine treatmentFDA approved Onzetra Xsail (Avanir Pharmaceuticals Inc.)— a fast-acting, low-dose sumatriptan dry powder formulation for the acute treatment of migraine with or without aura in adults.
New drug approved for chemotherapy nauseaFDA recently approved granisetron (Sustol, Heron Therapeutics) extended-release injection to prevent nausea and vomiting associated with repeat courses of chemotherapy.
Merck value rises after new Keytruda approvalMerck’s Wall Street value is climbing after its cancer drug pembrolizumab (Keytruda) received yet another approval from FDA.
FDA approves drug for pregnant women with HIVFDA recently approved an expansion to the prescribing information for darunavir (Prezista, Janssen Therapeutics), to treat pregnant women with HIV.
New Products: FDA approves combination regimen to treat advanced RCCOther products discussed in this roundup include a smart-mobile connected ultrasound device, treatments for RCC, and more.
FDA approves first once-monthly injection to lower cholesterolFDA approved evolocumab (Repatha, Amgen) Pushtronex system, the first monthly single-dose injection of a PCSK9 inhibitor. Repatha was already approved by FDA as the only PCSK9 inhibitor with a monthly dose last August.