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FDA Seeks Permanent Injunctions against Two Stem Cell Clinics americanpharmaceuticalreview
May 18, 2018
The U.S. Food and Drug Administration (FDA), in two complaints filed today in federal court, is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current
UCB Announces BRIVIACT Approved by FDA americanpharmaceuticalreview
May 18, 2018
UCB announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the anti-epileptic drug (AED) BRIVIACT (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in the treatme
FDA Expands Approval of Gilenya americanpharmaceuticalreview
May 18, 2018
The U.S. Food and Drug Administration (FDA) approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older.
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia americanpharmaceuticalreview
May 18, 2018
The U.S. Food and Drug Administration (FDA) approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy
FDA Approves First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults americanpharmaceuticalreview
May 18, 2018
The U.S. Food and Drug Administration (FDA) approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
FDA Approves Expanded Indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents drugs
May 17, 2018
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients drugs
May 17, 2018
UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the company’s newest anti-epileptic drug (AED) Briviact (brivaracetam) oral formulations indicated
FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis drugs
May 17, 2018
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra® (tocilizumab)
Aerie Pharmaceuticals Submits NDA to FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% drugs
May 17, 2018
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery,
FDA Approves Retacrit drugs
May 17, 2018
The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease

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