New Approvals – Page 22 – media

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
- 784
- November 1, 2017
Calquence FDA mantle cell lymphoma New Approvals
Abbott rolls out smartphone-connected ICM in the U.S.

The FDA has cleared Abbott’s smartphone-compatible insertable cardiac monitor (ICM), the first and only device of its kind in the U.S. This provides patients and physicians with another way to monitor and diagnose abnormal heart rhythms.
- Source: Guidedsolutions
- 592
- October 25, 2017
heart rhythms ICM New Approvals
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
- 459
- October 25, 2017
Bydureon diabetes New Approvals
Alexion Wins Expanded Approval for Blockbuster Drug Soliris

Alexion Pharmaceuticals Inc. is set to secure even more revenue from its blockbuster drug Soliris, the most expensive drug in the world.
- Source: Biospace
- 811
- October 25, 2017
Alexion New Approvals Soliris
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
Ebola vaccine wins approval from regulators

China's top food and drug authority announced on Friday that it has approved the country's first vaccine for Ebola virus disease.
- Source: Chinadaily
- 718
- October 23, 2017
CFDA Ebola 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
GlaxoSmithKline wins first-ever nod for blockbuster vaccine prospect Shingrix

Just as GlaxoSmithKline nears a decision from the U.S. FDA for its key shingles vaccine, Shingrix, Canada has become the first country to approve the shot—and it's a key piece of CEO Emma Walmsley's prescription for growth at the drugmaker.
- Source: fiercepharma
- 605
- October 19, 2017
New Approvals shingles vaccine
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
- 743
- October 19, 2017
cancer CAR–T FDA New Approvals

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.