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FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia europeanpharmaceuticalreview
April 24, 2018
The FDA has approved Crysvita, the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia, a rare, inherited form of rickets…
Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter biospace
April 24, 2018
SurModics, Inc.announced it received FDA 510(k) clearance for its .018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed and indicated for a broad range of peripheral vascular applications.
Sage Therapeutics’ Postpartum Depression Drug Heads to the FDA biospace
April 24, 2018
SAGE Therapeutics, located in Cambridge, Massachusetts, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for brexanolone (SAGE-547) to treat postpartum depression (PPD).
The FDA Giveth and Taketh Away: Grants Pfizer's MenB Breakthrough Therapy Designation and Turns Down a Biosimilar biospace
April 24, 2018
The U.S. Food and Drug Administration (FDA) granted Pfizer’s Trumenba, a vaccine for meningococcal B disease in children ages one to nine years, Breakthrough Therapy Designation.
FDA Takes Steps to Advance Development of Products for Treating OUD americanpharmaceuticalreview
April 23, 2018
The U.S. Food and Drug Administration (FDA) announced the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD).
FDA Accepts sNDA for the De Novo Indication for ENVARSUS XR americanpharmaceuticalreview
April 23, 2018
Veloxis Announces US Food and Drug Administration (FDA) Accepts Standard Review Company's Supplemental New Drug Application (sNDA)
U.S. FDA grants Fast Track designation for Polyphor’s innovative immuno-oncology candidate balixafortide in combination with eribulin as third line therapy for metastatic breast cancer biospace
April 23, 2018
Polyphor announced today that FDA has approved Fast Track for its new immune tumor candidate balixafortide (POL6326) and Eribulin.
FDA Accepts Veloxis's Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR® biospace
April 23, 2018
Veloxis Pharmaceuticals A/S announced today that the FDA has accepted for standard review the Company's supplemental New Drug Application (sNDA)
FDA Panel Recommends GW Pharma’s Cannabis-based Drug for Seizure Disorders biospace
April 23, 2018
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously recommended the approval of London, UK-based GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with LGS and Dravet syndrome.
FDA clears first therapy for inherited rickets pharmatimes
April 20, 2018
US regulators have approved the first drug to treat adults and children with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets.

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