The European Commission has approved the marketing authorization application (MAA) for MSD's SYCREST (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.

New research on how skin cancer begins has identified adjacent cancer cells that scientists are calling co-conspirators in the genesis of melanoma, in findings that could someday hold the key to predicting, preventing and stopping this hard-to-treat cancer before it spreads.

European Commission has issued a positive decision for the approval of once-daily AstraZeneca's SEROQUEL XR (quetiapine fumarate) extended release tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.

Elite Pharmaceuticals has acquired a currently approved Abbreviated New Drug Application (ANDA) for naltrexone hydrochloride 50 mg tablets from Mikah Pharma.

FDA has granted orphan drug status to Stromedix's STX-100 for the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung.

Caris Life Sciences has appointed Les Paul as senior vice president of medical affairs. Mr Paul has 30 years of experience including a range of experiences as a practicing physician, chief medical officer and leader of medical affairs.

Reckitt Benckiser Pharmaceuticals has received an approval from the FDA for its New Drug Application (NDA) to manufacture and market Suboxone sublingual film.

Bio-pharmaceutical company Achaogen has won a contract from The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services.

Bayer HealthCare’s dermatology business Intendis and KYTHERA Biopharmaceuticals have signd an agreement to develop and commercialize adipolytic agent ATX-101.