Search Results for “FDA” – Page 74 – media

GSK’s investigational BCMA antibody-drug conjugate receives Breakthrough Therapy Designation from US FDA for relapsed and refractory multiple myeloma

In October, the European Medicines Agency (EMA) granted PRIME designation to GSK2857916 for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate.
- Source: gsk
- 552
- November 3, 2017
inhibitor multiple myeloma New Approvals refractory relapsed
AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

AbbVie, a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. , announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated for the management of endometriosis with associated pain.
- Source: news.abbvie
- 729
- November 2, 2017
antagonist biopharmaceutical GnRH New Approvals
FDA approves new treatment for adults with mantle cell lymphoma

The U.S. Food and Drug(FDA) Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
- Source: Prnewswire
- 777
- November 1, 2017
Calquence FDA mantle cell lymphoma New Approvals
FDA Calls BioMarin’s Hemophilia A Drug a Breakthrough

BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) granted its valoctocogene roxaparvovec for Hemophilia A Breakthrough Therapy Designation.
- Source: biospace
- 801
- October 31, 2017
Clinical Trial FDA hemophilia A
US FDA finalises new guidelines for medical device development

The US Food and Drug Administration (FDA) has announced new measures to promote medical device innovation and provide patients with fast access to beneficial technologies.
- Source: medicaldevice-network
- 457
- October 30, 2017
FDA medical device
FDA warns UVLrx Therapeutics over clinical trial missteps

The FDA this week released a warning letter it sent to UVLrx Therapeutics over issues with an unapproved study of an intravascular catheter, citing failures to obtain approval for the trial alongside a number of other violations.
- Source: massdevice
- 781
- October 26, 2017
FDA intravascular catheter Market Views
FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon® BCise™ (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control.
- Source: AstraZeneca
- 456
- October 25, 2017
Bydureon diabetes New Approvals
Novartis combination adjuvant therapy Tafinlar® + Mekinist® receives FDA Breakthrough Therapy Designation

Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection. Tafinlar in combination with Mekinist is in development to become the first adjuvant treatment specifically for melanoma patients with a BRAF V600 mutation.
- Source: novartis
- 705
- October 24, 2017
BTD FDA Melanoma New Approvals
Semaglutide receives positive 16-0 vote in favour of approval from FDA Advisory Committee

Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained.
- Source: finance.yahoo
- 602
- October 20, 2017
diabetes FDA New Approvals semaglutide
Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA

Kite, a Gilead Company, announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
- Source: Businesswire
- 676
- October 20, 2017
B-cell lymphoma CAR–T FDA Market Views Yescarta

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