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About 338 results for "fda centre for drug evaluation and re..."

Biosimilars are regulated differently in China

Introduction The Centre for Drug Evaluation (CDE) the technical review body under the China Food and Drug Administration (CFDA) released the Technical Guideline for the Research, Development and Evaluation of Biosimilars (Tentative) on February ... Lexology, 1 week ago

Otsuka Pharma, H. Lundbeck A/S (LUN.CO) Beat Competitors With FDA Approval of Schizophrenia Drug 7/13/2015

TOKYO & VALBY, Denmark--( BUSINESS WIRE )--Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved REXULTI ® (brexpiprazole) as an adjunctive ...
 ClinicSpace2 weeks ago Otsuka Pharma, H. Lundbeck A/S Beat Competitors With FDA Approval of Schizophrenia Drug  BioSpace2 weeks ago U.S. FDA Approves Otsuka and Lundbeck's REXULTI® (Brexpiprazole) as Adjunctive Treatment for Adults with Major Depressive Disorder and as a Treatment for Adults with Schizophrenia  CNBC3 weeks ago OTSUKA : U.S. FDA Approves Otsuka and Lundbeck's REXULTI® (Brexpiprazole) as Adjunctive Treatment for Adults with Major Depressive Disorder and as a Treatment for Adults with Schizophrenia  4 Traders3 weeks ago
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NIH provides interim corrective action plan for clinical centre PDS

The National Institutes of Health (NIH) has submitted interim corrective action plans to the US Food and Drug Administration (FDA) to address problems with sterile manufacturing processes identified in its Pharmaceutical Development Section (PDS) ...
 PharmaBiz1 month ago
News.am

Anti-ageing pill may become available in several years

Doctors and scientists want drug regulators and research funding agencies to consider medicines that delay ageing-related disease as legitimate drugs. Such treatments have a physiological basis, researchers say, and could extend a person's healthy ...
 News.am1 week ago Anti-ageing pill pushed as bona fide drug (Metformin)  National AIDS Treatment Advocacy Project1 month ago
European Pharmaceutical Review

FDA approves Iressa for first-line treatment of patients with a type of metastatic lung cancer

The US Food and Drug Administration (FDA) has approved AstraZeneca's Iressa (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor ...
 European Pharmaceutical Review2 weeks ago

IND For Phase 1b/2 Ovarian Cancer Trial Transferred To Prescient Therapeutics 6/29/2015

Melbourne, Australia: Prescient Therapeutics (ASX:PTX), a clinical stage oncology company, has notified the US Food and Drug Administration (FDA) of the transfer of the Investigational New Drug (IND) for its novel drug candidate PTX-200 (formerly ...
 ClinicSpace1 month ago U.S. FDA Reactivates Prescient Therapeutics's IND For PTX-100 Breast Cancer Trial 6/10/2015  ClinicSpace1 month ago IND reactivated for Prescient breast cancer drug  Australian Life Scientist1 month ago PRESCIENT THERAPEUTICS : IND for Phase 1b/2 Ovarian Cancer Trial Transferred to Prescient  4 Traders1 month ago
Proactive Investors.co.uk

Shard Market Eye - Motif Bio all set for the clinical trial programme

() All set for the clinical trial programme Motif is developing a best-in-class drug that is targeting bacteria that are resistant to most other commonly used drugs. The FDA will be satisfied with two carefully constructed clinical ...
 Proactive Investors.co.uk6 days ago Novel cancer drug candidate developed in Singapore advances into clinical trials  News-Medical.Net2 weeks ago First Made-in-Singapore Cancer Drug Enters Clinical Testing  PharmaAsia1 week ago :: 16, Jul 2015 :: FIRST MADE-IN-SINGAPORE CANCER DRUG ENTERS CLINICAL TESTING  SG Press Centre2 weeks ago
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NDTV

'Smartphones Pose Danger for Wearers of Cardiac Devices Like Pacemakers'

If you wear a cardiac device such as a pacemaker, better keep away from smartphones, researchers say. "Pacemakers can mistakenly detect electromagnetic interference (EMI) from smartphones as a cardiac signal, causing them to briefly stop working," ...
 NDTV1 month ago Smartphones pose danger for cardiac device users  Times of India1 month ago
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FDA's High Bar For Breakthrough Therapy Designations

S anofi (NYSE: SNY ) gaining breakthrough designation for its phase II project olipudase alfa underscores the risks and benefits of seeking this regulatory accolade for major scientific advances. The FDA has been approving roughly one out of every ...
 Seeking Alpha1 month ago

Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study

Bilal Chughtai , assistant professor 1 , Jialin Mao , research analyst 2 , Jessica Buck , medical student 1 , Steven Kaplan , professor 1 , Art Sedrakyan , professor 2 1 Department of Urology, Weill Medical College of Cornell University, New ...
 British Medical Journal2 months ago
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