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FDA Accepts Supplemental New Drug Application for Allergan’s VRAYLAR americanpharmaceuticalreview
March 09, 2017
Allergan has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine), seeking the addition of new clinical data evaluating VRAYLAR for the maintena
FDA Accepts New Drug Application and Grants Priority Review for Enasidenib in Relapsed or Refractory drugs.com
March 07, 2017
Celgene Corporation and Agios Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene's New Drug Application.
PTC Therapeutics Announces FDA Acknowledgment of New Drug Application Filing for Translarna for the drugs.com
March 07, 2017
PTC Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the filing over protest of PTC's New Drug Application (NDA)...
FDA Approves First Treatment for Frequent Urination at Night Due to Overproduction of Urine americanpharmaceuticalreview
March 07, 2017
The U.S. Food and Drug Administration has approved Noctiva nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria
FDA approves Serenity’s Noctiva nasal spray for frequent night-time urination pharmaceutical-technology
March 07, 2017
The US Food and Drug Administration (FDA) has approved Noctiva (desmopressin acetate) nasal spray treatment for adults who wake up at least two times every night due to overproduction of urine, a condition known as nocturnal polyuria.
FDA approves first treatment for excessive night-time urination pharmafile
March 07, 2017
The FDA has approved Noctiva, administered as a nasal spray, for the treatment of people
LSNE Completes Two FDA Inspections cphi-online
March 07, 2017
FDA PAI and general GMP inspection of two aseptic manufacturing plants and QC laboratory completed successfully
US FDA approves Xermelo with SSA therapy to treat carcinoid syndrome diarrhoea pharmaceutical-technology
March 03, 2017
The US Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals’ Xermelo (telotristat ethyl) tablets in ...
FDA Approves Odactra for House Dust Mite Allergies americanpharmaceuticalreview
March 03, 2017
The U.S. Food and Drug Administration has approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conj
FDA approves Odactra for house dust mite allergies worldpharmanews
March 02, 2017
The U.S. Food and Drug Administration today approved Odactra the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis).

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