MYLAN N.V.: Mylan Launches Authorized Generic of Ampyra® Tablets
Mylan's Dalfampridine Extended-Release Tablets, 10 mg, are indicated for patients with multiple sclerosis Read More »
Mylan's Dalfampridine Extended-Release Tablets, 10 mg, are indicated for patients with multiple sclerosis Read More »
Rite Aid Corporation (NYSE: RAD) announced that the company has established its Chemical Policy and expanded Restricted Substances List as part of ongoing efforts to continue meeting customer expectations for chemical management and product safety. Read More »
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. Read More »
Triple-S Management Corporation (NYSE: GTS), announced that its managed care subsidiary, Triple-S Salud, Inc., on its behalf and on behalf of its Medicare Advantage subsidiary, Triple-S Advantage, Inc. ("Triple-S" or the "Company"), has entered into a three-year agreement with Abarca Health, LLC, a leading pharmacy benefits manager (PBM) in Puerto Rico, to consolidate the management of its prescription drug benefit programs for its Commercial and Medicare business lines. Read More »
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Read More »
Novartis announced today that the European Commission (EC) has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection. Read More »
MYGRIN® 'Helping you turn the face of pain into a grin Read More »
The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye). Read More »
Ludovic Fenaux to lead Vertex’s expanding International organization and Simon Bedson announces retirement Read More »
Eisai Inc. and Merck (NYSE : MRK ), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read More »
Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). Read More »
For the remainder of 2018, Astellas will not increase any of the company’s drug prices in the United States. Read More »
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it has added another product to its growing generic portfolio, supporting its commitment to expanding and diversifying its product offerings. Read More »
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved GRANIX® (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older. Read More »
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) and Neuren Pharmaceuticals Limited (ASX: NEU) announced today that they have entered into an exclusive North American License Agreement for the development and commercialization of trofinetide for Rett syndrome and other indications Read More »
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote approved by the U.S. Food and Drug Administration (FDA) for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Read More »
Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, today announced that Allergan's wholly-owned subsidiary, Allergan Pharmaceuticals International Limited (Allergan), has exercised its option to develop and commercialize EDIT-101 globally for the treatment of LCA10 Read More »
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved GRANIX® (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older. Read More »
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Read More »
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Genentech, a member of the Roche Group, has dosed the first patient in a Phase 3 study of a fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin®) for subcutaneous administration using Halozyme's proprietary ENHANZE® drug-delivery technology in combination with chemotherapy. Read More »