February is kicking off with a number of PDUFA dates for the U.S. Food and Drug Administration (FDA) as well as a cancer advisory committee meeting. Here’s a look.

Adamas Pharmaceuticals’ Gocovri for OFF Episodes in Parkinson’s

Coming off a stellar year, when a record 53 new molecular entities were approved, 2021 has a lot to live up to. NMEs are a measure of innovation among biopharma companies, as they refer to drugs containing an active ingredient that has never been approved previously.

Although the calendar for drug approval decisions, known as PDUFA dates, for January was fairly light, most verdicts issued in the month were positive. Among the drugs approved in the month were Merck & Co., Inc.'s (NYSE: MRK) heart failure drug, an expanded indication for Pfizer Inc.'s (NYSE: PFE) lymphoma drug and Aurinia Pharmaceuticals Inc's (NASDAQ: AUPH) kidney inflammation drug.

Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) On 4/19/18 announced positive data from EASE LID 2, the company’s two-year Phase 3 open-label study of GOCOVRI™ (amantadine) extended release capsules, the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.