FDA Calendar

PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.

Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

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Company Name
Adamis Pharmaceuticals Corp
Symjepi (sNDA)
FDA decision on low dose Symjepi (0.15mg) for the emergency treatment of anaphylaxis
Akcea Therapeutics Inc.
Volanesorsen (NDA)
FDA decision on Volanesorsen for the treatment of familial chylomicronemia syndrome (FCS).
Tetraphase Pharmaceuticals
Eravacycline (NDA)
FDA decision on Eravacycline for the treatment of complicated intra-abdominal infections
Mallinckrodt plc
Stannsoporfin (NDA)
FDA decision on Stannsoporfin for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice
Amicus Therapeutics Inc.
Galafold (NDA)
FDA to review NDA of Galafold for diagnosis of Fabry disease
Arbutus Biopharma Corp.
Patisiran (NDA)
FDA decision on Alnylam's Patisiran for hereditary ATTR (hATTR) amyloidosis
Alnylam Pharmaceuticals Inc.
Patisiran (NDA)
FDA decision on Patisiran for the treatment of hereditary ATTR (hATTR) amyloidosis
Pain Therapeutics Inc
FDA panel to review resubmitted NDA of REMOXY ER for Management of severe pain
Progenics Pharmaceuticals Inc
Azedra (NDA)
FDA decision on Azedra for the treatment of malignant and/or recurrent pheochromocytoma and paraganglioma
Akcea Therapeutics Inc.
FDA decision on Inotersen for hereditary TTR amyloidosis (hATTR)
Dermira Inc.
Glycopyrronium tosylate (NDA)
FDA decision on Glycopyrronium tosylate for primary axillary hyperhidrosis
GW Pharmaceuticals PLC
Epidiolex (NDA)
FDA decision on Epidiolex for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome
Achaogen Inc.
Plazomicin (NDA)
FDA decision on Plazomicin for the treatment of complicated urinary tract infections, and bloodstream infections
scPharmaceuticals Inc.
Furoscix (505(b)(2) NDA)
FDA decision on Furoscix for treatment of worsening, or decompensated, heart failure outside of the inpatient setting
Teva Pharmaceutical Industries Limited
Fremanezumab (BLA)
FDA decision on Fremanezumab for the treatment of migraine
pharma-032318.jpg Today's Daily Dose brings you news about approval of Amicus Fabry disease drug in Japan; commercial launch of La Jolla's GIAPREZA in the U.S.; Emergent Bio's stock repurchase program; better-than expected quarterly financial results of HTG Molecular Diagnostics; FDA postponing the decision date on Progenics' AZEDRA, and reverse stock split of Ritter.
pharma-032118.jpg Today's Daily Dose brings you news about the collaboration inked between Regeneron and Alnylam; progress in Edwards Lifesciences' PARTNER 3 trial; Sophiris Bio's near-term clinical trial catalyst; FDA approval of Lucentis 0.3 mg prefilled syringe and Fast Track designation for Fennec's investigational drug PEDMARK.
pharma-032018.jpg Today's Daily Dose brings you news about Antibe's safety study results of ATB-346; Immunovaccine's upcoming clinical trial catalysts; Chiasma's progress in the development of octreotide capsules in the treatment of acromegaly; KemPharm's pharmacokinetic study with a KP415/d-methylphenidate in ADHD and NovaBay's strong financial performance.
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Graphene, a form of carbon, which was discovered in 2004, is said to have the potential for use in a variety of applications, say in the fields of electricity, conductivity, energy generation and storage, sensors, batteries, and many more. Now, researchers have identified a new use for this material - making better hair dyes.
A study published by Oxford University Press has found that smokers are at a greater risk of hearing loss. The study involved 50,000 participants, aged 20-64 years, who were followed up for a maximum of 8 years in Nicotine & Tobacco Research.
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