New Approvals – Page 25 – media

Sanofi wins tentative FDA nod for Admelog insulin lispro injection

Sanofi announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus.
- Source: yahoo
- 740
- September 7, 2017
Company Insight diabetes FDA insulin New Approvals
FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma, one of the most common blood cancers among adults. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.
- Source: biospace
- 564
- September 5, 2017
cancer FDA follicular lymphoma New Approvals sBLA
Apollo Endosurgery gets CE-Mark for managed weight loss system

Apollo Endosurgery has received CE-Mark for its ORBERA365 Managed Weight Loss System allowing commercialisation in the European Union (EU) and member countries of the European Economic Area.
- Source: medicaldevice-network
- 888
- September 4, 2017
CE EU New Approvals weight loss
FDA approves Teva’s Austedo for tardive dyskinesia

Teva’s Austedo is now the first and only therapy approved in the US to treat both tardive dyskinesia and chorea associated with Huntington’s disease.
- Source: news.open-medical
- 661
- September 1, 2017
chorea FDA New Approvals tardive dyskinesia Teva
FDA Approves New Antibiotics to Treat Kidney Infections by “Superbugs”

Adult peoples with complicated urinary tract infections (cUTI) like pyelonephritis– a type of kidney infection caused by specific bacteria- suffer from many inconvenient problems like painful urination. It may lead to serious life threatening conditions including permanent kidney damage.
- Source: medgenera
- 741
- August 31, 2017
cUTI kidney New Approvals pyelonephritis
EUSA bags EU approval for kidney cancer drug

The European Commission has licensed EUSA Pharma’s Fotivda for the management of adult patients with advanced kidney cancer across the European Union as well as Norway and Iceland.
- Source: open-medical
- 576
- August 30, 2017
cancer inhibitor kidney New Approvals
Europe’s first stem cell therapy backed by NICE

Chiesi's Holoclar, the first stem-cell therapy to be cleared by European regulators, has received a green light for use on the NHS in England and Wales to treat a rare sight condition.
- Source: pharmatimes
- 860
- August 29, 2017
New Approvals NHS stem-cell therapy
US OKs first drug for dyskinaesia in Parkinson’s patients

US regulators have approved the first and only treatment option to treat dyskinaesia in patients with Parkinson's disease.
- Source: pharmatimes
- 701
- August 28, 2017
dyskinaesia New Approvals Parkinson
Titan wins FDA nod to study Parkinson’s implant

Titan Pharmaceuticals’ stated today that their ropinirole implant, designed to treat the symptoms of Parkinson’s disease, was cleared by the FDA today as a new drug application.
- Source: drugdeliverybusiness
- 656
- August 25, 2017
Clinical Trials formulation implant New Approvals Parkinson
New flu vaccine approved for UK use

The adjuvanted trivalent influenza vaccine Fluad for use in people aged 65 years or older has been cleared by the Medicines and Healthcare products Regulatory Agency.
- Source: pharmatimes
- 675
- August 23, 2017
influenza New Approvals trivalent vaccine

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