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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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