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Onpattro approved by FDA as first treatment for polyneuropathy pharmaceutical-technology
August 15, 2018
Alnylam Pharmaceuticals has obtained approval from the US Food and Drug Administration (FDA) for Onpattro (patisiran) to treat peripheral nerve disease (polyneuropathy) in adults with hereditary transthyretin-mediated amyloidosis (hATTR).
FDA approves first direct-to-consumer contraceptive app Natural Cycles pharmaceutical-technology
August 15, 2018
The US Food and Drug Administration (FDA) has approved Sweden-based Natural Cycles, making it the first direct-to-consumer smartphone app used for digital contraception to be marketed in the country.
FDA approves RNA therapy for rare genetic disease pharmafile
August 14, 2018
The US Food and Drug Administration has approved the RNA-based therapy Onpattro, for the treatment of the rare genetic disease polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.
FDA approves flexible, reusable contraceptive ring for yearlong use fiercebiotech
August 14, 2018
The FDA approved the first in a new class of self-administered hormonal contraceptives, formed as a reusable, flexible silicone ring that is placed in the vagina for three weeks at a time for up to an entire year.
FDA approves Amicus' Galafold for Fabry disease biospectrumasia
August 14, 2018
The efficacy of Galafold was demonstrated in a six-month, placebo-controlled clinical trial in 45 adults with Fabry disease.
FDA approved more generics in July than any previous month pharmafile
August 13, 2018
FDA Commissioner Scott Gottlieb took to Twitter to announce the news that the FDA smashed its previous record for number of generic drug approvals in a single month, authorising a total of 126 such medications throughout July this year.
FDA approves Kyowa Kirin’s Poteligeo to treat two lymphoma types pharmaceutical-technology
August 13, 2018
The US Food and Drug Administration (FDA) has granted approval to biotechnology company Kyowa Kirin’s Poteligeo (mogamulizumab-kpkc) injection to treat adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS).
FDA approves first generic drug under new CGT designation pharmaceutical-technology
August 13, 2018
The US Food and Drug Administration (FDA) has granted its first competitive generic therapy (CGT) designation to Apotex’s potassium chloride oral solution for hypokalemia in patients on diuretics.
FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD) drugs
August 13, 2018
Ironshore Pharmaceuticals & Development, Inc. (“Ironshore”) a wholly owned subsidiary of Highland Therapeutics Inc.
FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease drugs
August 13, 2018
The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.

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