Press Releases

Allergan plc announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S....

CSL announced that the US FDA has approved Seqirus’ FLUCELVAX QUADRIVALENT™ (Influenza Vaccine), the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. FLUCELVAX QUADRIVALENT helps protect against the two...

Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year Sandoz is seeking approval for all indications included in the reference product's label. Sandoz' submission includes data from multiple clinical trials...

Janssen Pharmaceuticals, Inc announced the U.S. FDA has approved INVOKAMET®, a fixed-dose combination therapy of INVOKANA® (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes. With this new approval, INVOKAMET® may now...

Bayer announced that it looks forward to engaging in constructive discussions with Monsanto regarding the proposed transaction. Bayer reiterated that its USD 122 per share all-cash proposal provides full and certain value for Monsanto shareholders. “We...

Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. IDegLira is a...

Chugai Pharmaceutical Co Ltd announced that it gained approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) on May 23, 2016, for “advanced or recurrent cervical cancer,” as new additional indication for the anti-cancer agent / anti-VEGF...