Erin Bastick
Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.
FDA clears new treatment for epileptic seizures
FDA has approved brivaracetam (Briviact, UCB, Inc.) as an add-on therapy for the treatment of partial onset-seizures in patients with epilepsy.
AstraZeneca drug a breakthrough therapy for bladder cancer
FDA has granted breakthrough therapy designation for durvalumab (MEDI4736, AstraZeneca) for the treatment of urothelial bladder cancer.
FDA expands use of hep C drug
FDA has approved expanded use of daclatasvir (Daklinza, Bristol-Myers Squibb) in combination with Gilead Sciences' Sovaldi (sofosbuvir), for the treatment of patients with chronic hepatitis C (HCV) genotype 1 or 3.
FDA expands Opdivo use for metastatic melanoma
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma.
FDA clears long-acting ADHD drug
FDA has approved amphetamine extended-release orally disintegrating tablet (Adzenys XR-ODT, Neos Therapeutics, Inc.) for the treatment of ADHD in patients 6 years and older.
Cosentyx gets thumbs up for 2 new indications
FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of adult patients with active ankylosing spondylitis and active psoriatic arthritis.
FDA approves new indication for Hib vaccine
FDA has approved an expanded age indication for Hib vaccine (Hiberix, GlaxoSmithKine).
FDA panel greenlights Probuphine for opioid addiction
FDA advisers recommended approval of the first long-acting, subdermal buprenorphine implant (Probuphine, Titan Pharmaceuticals, Inc. and Braeburn Pharmaceuticals) for the maintenance treatment of opioid addiction.
Pacira makes nice with FDA; encouraging for Exparel
Amicable resolution between FDA and Pacira Pharmaceuticals, Inc., which reaffirms the broad indication for Exparel (bupivacaine liposome injectable suspension).
Expanded age indication cleared for Gardasil 9 in males
FDA approved expanded age indication for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9, Merck) in males.