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Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates

Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates
Most Food and Drug Administration decisions scheduled for February were positive, and more importantly five new molecular entities passed FDA muster.

NME approvals for the month included EMD Serono's Tepmetko for treating adult patients with certain types of non-small cell lung cancer, Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) cholesterol drug Evkeeza and Sarepta Therapeutics Inc's (NASDAQ:SRPT) Duchenne muscular dystrophy drug Amondys 45.

Mallinckrodt PLC (OTC:MNKKQ) is forced to wait, as the FDA deferred action on its biologics license application for StrataGraft for deep partial-thickness burns. The delay is due to the FDA's inability to complete site inspection.

Here are the key decisions due for March:

KemPharm's Novel Formulation Of ADHD Drug Awaits Clearance



Company: KemPharm Inc (NASDAQ:KMPH) & Aquestive Therapeutics Inc (NASDAQ:AQST)

Type of Application: New drug application

Candidate: KP415

Indication: Attention deficit hyperactivity disorder

Date: March 2
See also:
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