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Ocular Therapeutix Announces FDA Acceptance of NDA Resubmission for Dextenza americanpharmaceuticalreview
July 24, 2018
Ocular Therapeutix has received acknowledgement from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for Dextenza has been received.
Statement by FDA Commissioner on Formation of New Work Group americanpharmaceuticalreview
July 24, 2018
As part of our public health mission, the Food and Drug Administration (FDA) monitors the pharmaceutical supply chain to support patient access to medically necessary drugs.
FDA Approves First Cancer Drug through New Oncology Review Pilot americanpharmaceuticalreview
July 24, 2018
The U.S. Food and Drug Administration (FDA) approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive,
FDA approves Tibsovo americanpharmaceuticalreview
July 24, 2018
The U.S. Food and Drug Administration (FDA) approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.
Aerie Announces Early Notification of FDA Acceptance of Roclatan americanpharmaceuticalreview
July 24, 2018
Aerie Pharmaceuticals has received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) earlier than scheduled, the FDA has completed its initial 60-day review of the NDA
FDA Approves Biosimilar Nivestym americanpharmaceuticalreview
July 24, 2018
Pfizer announced that the United States Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product.
FDA Approves New Indications for Zomacton americanpharmaceuticalreview
July 24, 2018
Ferring Pharmaceuticals the U.S. Food and Drug Administration (FDA) has approved Zomacton (somatropin) for injection in four additional pediatric indications:
FDA Approves Symtuza americanpharmaceuticalreview
July 24, 2018
The U.S. Food and Drug Administration (FDA) has approved Janssen's Symtuza, the first and only complete, darunavir-based single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically su
FDA targets price-gouging drugmakers with plan to import rival products fiercepharma
July 23, 2018
If you’re an off-patent drug sitting pretty with no rivals—generic or otherwise—enjoy it while you can. To stir up competition, FDA is looking at importing drugs that are approved in other countries but not yet in the U.S.
FDA Approves Krintafel drugs
July 23, 2018
London UK; Philadelphia US; Geneva, Switzerland - July 20, 2018 -- GSK and Medicines for Malaria Venture (MMV) today announced that the United States Food and Drug Administration (FDA) has approved

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