New Approvals – Page 16 – media

U.S. Food and Drug Administration Approves Gilead’s Biktarvy®

Gilead Sciences, Inc. on February 7 announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
- Source: Finchannel
- 789
- February 9, 2018
Biktarvy HIV-1 New Approvals STR
FDA Calls Bay Area Zogenix’s Dravet Syndrome Drug a Breakthrough

Zogenix Announces Receipt of FDA Breakthrough Therapy Designation for ZX008 in Dravet Syndrome.
- Source: Biospace
- 503
- February 8, 2018
Dravet syndrome FDA New Approvals ZX008
AMAG Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application (sNDA) for Feraheme® (ferumoxytol injection)

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has approved its application to broaden the existing label for Feraheme® (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron.
- Source: Amagpharma
- 698
- February 8, 2018
chronic kidney disease FDA Feraheme New Approvals
Scientists see positive results from 1st ever gene editing therapy

A second patient has been treated in a historic gene editing study in California, and no major side effects or safety issues have emerged from the first man’s treatment nearly three months ago, doctors revealed Tuesday.
- Source: NYPost
- 498
- February 7, 2018
gene editing Gene therapy New Approvals
Empatica’s consumer-facing epileptic seizure-detecting wearable gets FDA clearance

Emaptica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone.
- Source: MobiHealthNews
- 760
- February 6, 2018
digital health epilepsy medical device New Approvals
Breakthrough status for Roche’s autism drug

Roche’s balovaptan has picked up a Breakthrough Therapy Designation in the US for its potential as a treatment for people with autism spectrum disorder (ASD), potentially placing the drug on a faster path to market.
- Source: pharmatimes
- 623
- February 5, 2018
ASD balovaptan New Approvals Roche
Final NHS nod for Janssen’s Imbruvica

Janssen’s Imbruvica will be routinely available on the NHS to treat certain patients with mantle cell lymphoma (MCL), after cost regulators issued a final green light for the drug.
- Source: Pharmatimes
- 531
- February 2, 2018
MCL New Approvals NHS
FDA Calls Roche’s Autism Drug a Breakthrough

An experimental Roche drug designed to improve social interaction in people with autism scored the U.S. Food and Drug Administration’s Breakthrough Therapy Designation.
- Source: Biospace
- 723
- January 31, 2018
autism New Approvals
Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Novartis AG (NYSE: NVS) today announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.
- Source: Novartis
- 492
- January 29, 2018
FDA GEP-NETs Lutathera® New Approvals
AstraZeneca’s PARP Inhibitor Lynparza Gets Approval in Japan

AstraZeneca AZN and partner Merck MRK announced that the Japanese Ministry of Health, Labour and Welfare has granted approval to its PARP inhibitor, Lynparza, as a maintenance therapy for relapsed ovarian cancer, irrespective of BRCA mutation status in patients who have responded to their last platinum-based chemotherapy.
- Source: finance.yahoo
- 679
- January 26, 2018
cancer inhibitor New Approvals ovarian

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