Check out the PDUFA Calendar:
https://www.biopharmcatalyst.com/calendars/pdufa-calendar
Stocks to keep an eye on in the lead up to Sept 30 for MSB:
- Mallinckrodt Pharmaceuticals (MNK) Prescription Drug User Fee Act (PDUFA) target action date is September 12. If approved, terlipressin would be the first FDA-approved treatment in the United States for adult patients with HRS-1, a life-threatening condition. AdCom 8-7 in favor.
- Aquestive Therapeutics (AQST) Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020. If approved by the FDA, Libervant will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 million refractory epilepsy patients. Libervant was designated by the FDA as an orphan drug in November 2016.
banter and General Discussion, page-1208
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