Horizon Therapeutics announces U.S. FDA acceptance of its new drug application to make Procysbi (cysteamine bitartrate) available as oral granules in packets

18 July 2019 - Horizon Therapeutics announced today that the U.S.FDA has accepted Horizon’s new drug application for Procysbi (cysteamine bitartrate) ...

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Durect announces that the FDA agreed to file the full response to the Posimir complete response letter as a complete Class 2 resubmission

17 July 2019 - User fee goal date is 27 December 2019. ...

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U.S. FDA accepts Allergan's new drug application for bimatoprost sustained release in patients with open-angle glaucoma or ocular hypertension

17 July 2019 - Filing included data from the Phase 3 ARTEMIS studies, which demonstrated that the majority of patients remained ...

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Seattle Genetics and Astellas announce submission of biologics license application to FDA for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer

16 July 2019 - Submission based on pivotal Phase 2 trial results recently presented at Annual Meeting of American Society of ...

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Eton Pharmaceuticals provides update on EM-100 program

12 July 2019 - Eton Pharmaceuticals today announced that the U.S FDA provided Eton’s partner with a complete response letter relating ...

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Janssen submits application to U.S. FDA seeking approval of new Darzalex (daratumumab) subcutaneous formulation

12 July 2019 - Submission inclusive of data from Phase 3 COLUMBA study presented at ASCO. ...

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Neurocrine Biosciences announces FDA acceptance of new drug application for opicapone as an adjunctive treatment for patients with Parkinson's disease

10 July 2019 - New drug application based on data from 38 clinical studies, including two Phase III studies, with more ...

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Horizon Therapeutics submits teprotumumab biologics license application for the treatment of active thyroid eye disease

10 July 2019 - Horizon Therapeutics announced today that it has submitted a biologics license application to the U.S. FDA ...

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FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma

10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...

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FDA accepts Merck’s supplemental biologics license applications for Keytruda (pembrolizumab) six-week dosing schedule for melanoma and multiple other indications

9 July 2019 - Merck today announced that the U.S. FDA has accepted for review six supplemental biologics license applications to ...

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RedHill Biopharma announces FDA acceptance of new drug application for Talicia

3 July 2019 - U.S. FDA accepts NDA for priority review. ...

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FDA accepts new drug application for INSYS Therapeutics’ naloxone nasal spray for the emergency treatment of known or suspected opioid overdose

3 July 2019 - INSYS Therapeutics announced today that its new drug application to the U.S. FDA for its investigational, proprietary ...

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Alnylam submits marketing authorisation application to the EMA for givosiran for the treatment of acute hepatic porphyria

1 July 2019 - Patients receiving givosiran in pivotal Phase 3 ENVISION study had a 74% mean reduction in annualised rate ...

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Puma Biotechnology submits a supplemental new drug application to U.S. FDA for neratinib to treat HER2-positive metastatic breast cancer

1 July 2019 -  Puma Biotechnology has submitted a supplemental new drug application to the U.S. FDA for neratinib in ...

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Aimmune submits marketing authorisation application to EMA for AR101 for peanut allergy

28 June 2019 - Aimmune Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for AR101, ...

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