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RSS FeedPosted by Michael Wonder on 20 Sep 2019
Emmaus Life Sciences announces withdrawal of marketing authorisation application to European Medicines Agency
19 September 2019 - Emmaus Life Sciences today announced the withdrawal of its marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 19 Sep 2019
Novartis has submitted application to EMA for approval of Cosentyx in nr-axSpA, which would be the fourth indication
17 September 2019 - 52-week data from the PREVENT study, to support FDA submission, are expected later in the year. ...
Posted by Michael Wonder on 18 Sep 2019
Biofrontera files label extension for Ameluz in EU to include treatment of actinic keratosis on extremities and trunk/neck
17 September 2019 - Biofrontera has filed a label extension for Ameluz with the EMA on August 28, 2019 to include ...
Posted by Michael Wonder on 18 Sep 2019
Vertical Pharmaceuticals announces submission of new drug application for RVL-1201
17 September 2019 - Vertical Pharmaceuticals today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 17 Sep 2019
FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus
17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response. ...
Posted by Michael Wonder on 16 Sep 2019
Verrica Pharmaceuticals submits new drug application to U.S. FDA for VP-102 for the treatment of molluscum contagiosum
16 September 2019 - No FDA approved treatments are currently available for this highly contagious, primarily paediatric, viral skin infection affecting ...
Posted by Michael Wonder on 16 Sep 2019
Seattle Genetics and Astellas announce U.S. FDA grants priority review for enfortumab vedotin biologics license application in locally advanced or metastatic urothelial cancer
16 September 2019 - FDA sets Prescription Drug User Fee action date for 15 March 2020. ...
Posted by Michael Wonder on 16 Sep 2019
Janssen submits application to U.S. FDA seeking first-in-class approval of Tremfya (guselkumab) for treatment of adults with active psoriatic arthritis
16 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license ...
Posted by Michael Wonder on 11 Sep 2019
Puma Biotechnology announces U.S. FDA acceptance of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer
11 September 2019 - Puma Biotechnology announced that the U.S. FDA has accepted for review its supplemental new drug application for ...
Posted by Michael Wonder on 11 Sep 2019
United Therapeutics announces FDA acceptance of Trevyent new drug application for review
11 September 2019 - United Therapeutics today announced that the U.S. FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 10 Sep 2019
Horizon Therapeutics announces the FDA has granted priority review of the teprotumumab biologics license application for the treatment of active thyroid eye disease
9 September 2019 - If approved, teprotumumab would be the first FDA approved medicine for this vision-threatening disease. ...
Posted by Michael Wonder on 09 Sep 2019
Allergan and Molecular Partners announce acceptance of U.S. FDA biologics license application and validation of EMA marketing authorisation for abicipar pegol in patients with neovascular (wet) age-related macular degeneration
9 September 2019 - Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of abicipar quarterly ...
Posted by Michael Wonder on 07 Sep 2019
Endo announces submission of biologics license application to FDA for collagenase clostridium histolyticum in patients with cellulite
6 September 2019 - Endo International announced today that the Company has submitted a biologics license application to the ...
Posted by Michael Wonder on 05 Sep 2019
GBT announces U.S. FDA acceptance of new drug application and priority review for voxelotor for the treatment of sickle cell disease
5 September 2019 - NDA supported by data from Phase 3 HOPE study, which demonstrated statistically significant and sustained improvements in ...
Posted by Michael Wonder on 05 Sep 2019
Tricida announces submission of new drug application for veverimer for the treatment of metabolic acidosis in patients with chronic kidney disease
4 September 2019 - New drug application submitted under the FDA’s accelerated approval program. ...