Apr 16, 2019 - The FDA accepts Novartis' (NVS) BLA seeking approval for brolucizumab for the treatment of wet AMD.
Apr 15, 2019 - Clovis Oncology (CLVS) halts mid-stage bladder cancer study evaluating Rubraca monotherapy. It is unlikely to provide meaningful clinical benefit as reviewed by an independent data monitoring committee.
Apr 12, 2019 - Merck (MRK) gets FDA approval to include overall survival data from the KEYNOTE-042 study on Keytruda's label.
Apr 12, 2019 - Glaxo (GSK) gets FDA approval for a new HIV medicine, Dovato. AstraZeneca (AZN)/Merck's (MRK) Lynparza gets approval in EU for metastatic breast cancer.
Apr 10, 2019 - AstraZeneca (AZN) and Merck gain an EU approval for Lynparza as a monotherapy for treating HER2-negative locally-advanced/metastatic breast cancer.
Apr 09, 2019 - Glaxo's (GSK) ViiV Healthcare gets FDA approval for a single-tablet two-drug regimen (2DR), Dovato for treatment naive HIV- 1 adults.
Apr 08, 2019 - Gilead (GILD) submits sNDA to the FDA for label expansion of Descovy as PrEP to reduce the risk of sexually acquired HIV-1 infection.
Apr 04, 2019 - Novartis' (NVS) generic arm Sandoz resubmits its BLA for the proposed biosimilar of Neulasta.
Apr 03, 2019 - Clovis (CLVS) presents interim data from the phase II study on Rubraca for the first-line maintenance treatment of patients with advanced pancreatic cancer.
Apr 02, 2019 - Novartis' (NVS) psoriasis drug gets approval in China. The company also signs an agreement to expand its biologics therapy manufacturing capability.