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Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive

ATLANTA, Jan. 17, 2018 /PRNewswire/ — Avion Pharmaceuticals, LLC, the makers of the Prenate® line of prescription prenatal vitamins, received approval of its new drug application (NDA) for the oral contraceptive Balcoltra (levonorgestrel and… Read More..

January 16th, 2018

FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC

Ridgefield, Conn., January 16, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) for the first-line treatment of patients… Read More..

January 16th, 2018

FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer

January 12, 2018 — The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a… Read More..

January 12th, 2018

Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism

SALT LAKE CITY, Utah, Jan. 10, 2018 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that the Bone, Reproductive and Urologic Drugs Advisory Committee (“BRUDAC”) of the U.S. Food and Drug… Read More..

January 10th, 2018

Ionis’ Inotersen NDA Accepted for Priority Review by the FDA

CARLSBAD, Calif., Jan. 8, 2018 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that its New Drug Application (NDA) for inotersen has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA)…. Read More..

January 8th, 2018
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