FDA – Page 18 – media

Shire Receives Orphan Drug Designation for Gene Therapy Candidate SHP654 (BAX 888) for the Treatment of Hemophilia A

Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced the U.S. Food and Drug Administration (FDA) awarded Orphan Drug Designation(ODD) to Shire`s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.
- Source: finance.yahoo
- 461
- October 27, 2017
FDA hemophilia A Orphan Drug Designation Shire
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
- 785
- October 26, 2017
FDA intravascular catheter Market Views
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
- 709
- October 24, 2017
BTD FDA Melanoma New Approvals
Shingrix approved in the US for prevention of shingles in adults aged 50 and over

GlaxoSmithKline plc announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
- Source: Gsk
- 619
- October 23, 2017
FDA New Approvals shingles vaccine
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
- 607
- 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
- 679
- October 20, 2017
B-cell lymphoma CAR–T FDA Market Views Yescarta
FDA Okays Another CAR T-Cell Therapy

The FDA has approved a second chimeric antigen receptor (CAR) T-cell therapy for cancer: Kite Pharma's axicabtagene ciloleucel (Yescarta) for the treatment of certain types of refractory large B-cell lymphoma, the agency announced.
- Source: medpagetoday
- 742
- October 19, 2017
cancer CAR–T FDA New Approvals
AstraZeneca’s Imfinzi gets speedy US review for lung cancer

US regulators have accepted an application by AstraZeneca and MedImmune to expand the scope of Imfinzi (durvalumab) to include patients with a certain form of lung cancer.
- Source: Pharmatimes
- 787
- October 18, 2017
AstraZeneca FDA Imfinzi (durvalumab) lung cancer
Respicardia gets FDA approval for remede system to treat sleep apnea

The US Food and Drug Administration (FDA) has approved Respicardia’s transvenous implantable neurostimulation system, remede, for moderate to severe central sleep apnea (CSA) in adults.
- Source: medicaldevice-network
- 521
- October 13, 2017
CSA FDA neurostimulation New Approvals
Roche secures FDA approval for Zika virus screening test

Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas Zika test to detect RNA of the Zika virus in human plasma samples.
- Source: medicaldevice-network
- 678
- October 11, 2017
FDA New Approvals plasma Zika

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