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Novartis' (NVS) BLA for Ophthalmology Drug Accepted by FDA http://www.zacks.com/stock/news/382060/novartis-nvs-bla-for-ophthalmology-drug-accepted-by-fda?cid=CS-ZC-FT-382060 Apr 16, 2019 - The FDA accepts Novartis' (NVS) BLA seeking approval for brolucizumab for the treatment of wet AMD.
Clovis Stalls Mid-Stage Rubraca Study for Bladder Cancer http://www.zacks.com/stock/news/380655/clovis-stalls-mid-stage-rubraca-study-for-bladder-cancer?cid=CS-ZC-FT-380655 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.
Merck's Keytruda Gets FDA Nod for Expanded Lung Cancer Group http://www.zacks.com/stock/news/379812/mercks-keytruda-gets-fda-nod-for-expanded-lung-cancer-group?cid=CS-ZC-FT-379812 Apr 12, 2019 - Merck (MRK) gets FDA approval to include overall survival data from the KEYNOTE-042 study on Keytruda's label.
Pharma Stock Roundup: AZN, MRK, GSK Get Regulatory Approvals, Sandoz Inks New Deal http://www.zacks.com/stock/news/379777/pharma-stock-roundup-azn-mrk-gsk-get-regulatory-approvals-sandoz-inks-new-deal?cid=CS-ZC-FT-379777 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.
AstraZeneca/Merck's Lynparza Wins EU Nod for Breast Cancer http://www.zacks.com/stock/news/377515/astrazeneca-mercks-lynparza-wins-eu-nod-for-breast-cancer?cid=CS-ZC-FT-377515 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.
Glaxo's Dovato Gets FDA Nod for Treatment-Naive HIV Patients http://www.zacks.com/stock/news/372924/glaxos-dovato-gets-fda-nod-for-treatment-naive-hiv-patients?cid=CS-ZC-FT-372924 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.
Gilead Files sNDA for Label Expansion of HIV Therapy Descovy http://www.zacks.com/stock/news/372671/gilead-files-snda-for-label-expansion-of-hiv-therapy-descovy?cid=CS-ZC-FT-372671 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.
Novartis Resubmits BLA to FDA for Biosimilar of Neulasta http://www.zacks.com/stock/news/370752/novartis-resubmits-bla-to-fda-for-biosimilar-of-neulasta?cid=CS-ZC-FT-370752 Apr 04, 2019 - Novartis' (NVS) generic arm Sandoz resubmits its BLA for the proposed biosimilar of Neulasta.
Clovis Posts Data on Rubraca Study for Pancreatic Cancer http://www.zacks.com/stock/news/370142/clovis-posts-data-on-rubraca-study-for-pancreatic-cancer?cid=CS-ZC-FT-370142 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.
Novartis Gets Approval for Psoriasis Drug Cosentyx in China http://www.zacks.com/stock/news/369420/novartis-gets-approval-for-psoriasis-drug-cosentyx-in-china?cid=CS-ZC-FT-369420 Apr 02, 2019 - Novartis' (NVS) psoriasis drug gets approval in China. The company also signs an agreement to expand its biologics therapy manufacturing capability.

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