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RSS FeedPosted by Michael Wonder on 08 Jul 2016
FDA approves first HPV test for use with SurePath Preservative Fluid
7 July 2016 - The U.S. FDA today approved the Roche cobas HPV Test as the first test for human papilloma ...
Posted by Michael Wonder on 08 Jul 2016
FDA approves Differin Gel 0.1% for over-the-counter use to treat acne
8 July 2016 - First retinoid approved for over-the-counter use. ...
Posted by Michael Wonder on 08 Jul 2016
NHS England, PTC reach agreement on Duchenne drug
8 July 2016 - Children in England suffering from a rare form of muscular dystrophy will soon be able to access ...
Posted by Michael Wonder on 08 Jul 2016
European Commission grants marketing authorization for Gilead’s Epclusa (sofosbuvir/velpatasvir) for the treatment of all genotypes of chronic hepatitis C
8 July 2016 - Epclusa is the first and only all-oral, single tablet regimen for all genotypes (1-6) of chronic hepatitis ...
Posted by Michael Wonder on 08 Jul 2016
Japan's Eisai weighs legal action in UK cancer drug row
8 July 2016 - Japan's Eisai said on Friday it would consider all options, including possible legal action, to fight delays ...
Posted by Michael Wonder on 08 Jul 2016
Idalopirdine granted fast track designation by U.S. FDA
7 July 2016 - Designation provides the opportunity for more frequent interactions with FDA during clinical development and potential eligibility for ...
Posted by Michael Wonder on 08 Jul 2016
Novartis announces FDA approval of Xolair (omalizumab) for paediatric allergic asthma
7 July 2016 - Extension of indication makes Xolair the first and only approved biologic for pediatric patients six years and ...
Posted by Michael Wonder on 07 Jul 2016
TGA approves Prometrium (progesterone)
7 July 2016 - The TGA has approved Besins Healthcare's Prometrium (progesterone). ...
Posted by Michael Wonder on 07 Jul 2016
TGA approves Descovy (emtricitabine with tenofovir alafenamide fumarate)
7 July 2016 - The TGA has approved Gilead Sciences' new dual combination product for patients with HIV infection. ...
Posted by Michael Wonder on 07 Jul 2016
NICE approves first drug from old Cancer Drugs Fund
7 July 2016 - Dozens of patients with leukaemia will now have an automatic right to the drug bosutinib rather than ...
Posted by Michael Wonder on 07 Jul 2016
Pfizer drug wins U.K. support following overhaul of Cancer Fund
7 July 2016 - Drug costs $58,000 a year before discounts from Pfizer. ...
Posted by Michael Wonder on 07 Jul 2016
Shire receives extension of market authorization in Europe for Revestive (teduglutide) for the treatment of paediatric patients with short bowel syndrome
7 July 2016 - First therapy indicated in the EU for use in patients aged one year and above with short ...
Posted by Michael Wonder on 06 Jul 2016
Charity calls on NICE to reverse Opdivo rejection
6 July 2016 - Kidney Cancer UK is calling on the National Institute for Health and Care Excellence to reverse a ...
Posted by Michael Wonder on 06 Jul 2016
Takeda receives European Commission approval of Adcetris (brentuximab vedotin) for consolidation treatment in post-transplant Hodgkin's lymphoma
6 July 2016 - Approval based on AETHERA Phase 3 data demonstrating 75 percent improvement in progression-free survival for patients treated ...
Posted by Michael Wonder on 06 Jul 2016
EMA goes electronic for PDCO opinions and subsequent EMA decisions
6 July 2016 - As of 1 August 2016, PDCO opinions and subsequent EMA decisions will be transmitted to applicants electronically ...