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RSS FeedPosted 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
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
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
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
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 ...
Posted by Michael Wonder on 05 Jul 2016
FDA approves treatment for AIDS symptoms
5 July 2016 - Insys says agency OKs Dronabinol oral solution after earlier application was rejected in 2014. ...
Posted by Michael Wonder on 05 Jul 2016
FDA approves first absorbable stent for coronary artery disease
5 July 2016 - The U.S. FDA today approved the first fully absorbable stent to treat coronary artery disease. The Absorb ...
Posted by Michael Wonder on 05 Jul 2016
Biogen and AbbVie’s once-monthly Zinbryta (daclizumab) approved in European Union for treatment of multiple sclerosis
5 July 2016 - Zinbryta significantly reduced multiple measures of disease activity in patients with relapsing forms of multiple sclerosis. ...
Posted by Michael Wonder on 04 Jul 2016
Allergan receives positive opinion through European decentralised procedure for Belkyra (deoxycholic acid) for patients with submental fullness
1 July 2016 - Belkyra (deoxycholic acid) expected to be the first non-surgical prescription medicine to treat submental fullness (or double ...
Posted by Michael Wonder on 04 Jul 2016
European Commission approves extended indication for Amgen's Kyprolis (carfilzomib) for the treatment of relapsed multiple myeloma patients
4 July 2016 - New indication allows Kyprolis to be used in combination with dexamethasone alone for appropriate patients. ...
Posted by Michael Wonder on 01 Jul 2016
AbbVie's Humira (adalimumab) receives U.S. FDA approval to treat adults with non-infectious intermediate, posterior and panuveitis
30 June 2016 - Approval marks the 10th approved indication for Humira in the United States and follows recent European Commission ...