Search Results for “FDA” – Page 184 – media

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
- 714
- 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
- 615
- October 23, 2017
FDA New Approvals shingles vaccine
China to adjust registration management for drugs and medical devices

To promote the adjustment of industrial structure and technological innovation in the drug and medical device sector, the Communist Party of China’s Central Committee and the State Council jointly released a guideline on the reform of the review and approval system, which came into effect on October 8, 2017.
- Source: china-briefing
- 1,183
- October 23, 2017
CFDA drug medical device Policy
‘Synthetic gene circuit’ may improve effectiveness of cancer immunotherapy

Synthetic gene circuits that only trigger powerful, tumor-specific immune responses when they detect certain disease markers may help immunotherapies to fight cancer more effectively, according to a new study.
- Source: medicalnewstoday
- 685
- October 20, 2017
cancer immunotherapies Synthetic gene
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
- 600
- October 19, 2017
New Approvals shingles vaccine
Takeda and HemoShear Therapeutics Enter into Exclusive Drug Discovery Partnership in Liver Diseases

Takeda Pharmaceutical Company Limited and HemoShear Therapeutics, LLC, a privately held biotechnology company, today announced a partnership to discover and develop novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH).
- Source: finance.yahoo
- 437
- October 18, 2017
Company Insight NASH therapeutics
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
- 783
- October 18, 2017
AstraZeneca FDA Imfinzi (durvalumab) lung cancer
Warp Drive Bio Forms Strategic Collaboration to Advance Novel Classes of Antibiotics

Warp Drive Bio, Inc., a drug discovery company developing therapeutics that exploit the molecules and mechanisms of nature, announced today that it has formed a strategic collaboration with Roche to discover and develop multiple novel classes of antibiotics. The serious global health threat of multi-drug-resistant bacterial infections has created an urgent need for new antibiotics with novel structures and mechanisms of action.
- Source: Businesswire
- 422
- October 17, 2017
antibiotics infections Market Views
Pfizer Presents Full Results from Phase 2 Study of Next-Generation Investigational ALK-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer

Pfizer Inc. today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated.
- Source: Pfizer
- 687
- October 17, 2017
Clinical Trials inhibitor Phase tyrosine kinase
NICE flip-flops to back Bristol’s Opdivo in head and neck cancer despite data ‘uncertainties’

Back in April, England’s cost watchdogs said they wouldn’t cover Bristol-Myers Squibb’s Opdivo in head and neck cancer due to “uncertain” clinical evidence. Now, though, they’re singing a different tune.
- Source: Fiercepharm
- 545
- October 16, 2017
New Approvals NHS Opdivo

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