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RSS FeedPosted by Michael Wonder on 18 Jul 2019
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) ...
Posted by Michael Wonder on 17 Jul 2019
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. ...
Posted by Michael Wonder on 17 Jul 2019
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 ...
Posted by Michael Wonder on 16 Jul 2019
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 ...
Posted by Michael Wonder on 13 Jul 2019
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 ...
Posted by Michael Wonder on 13 Jul 2019
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. ...
Posted by Michael Wonder on 11 Jul 2019
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 ...
Posted by Michael Wonder on 11 Jul 2019
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 ...
Posted by Michael Wonder on 10 Jul 2019
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 ...
Posted by Michael Wonder on 09 Jul 2019
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 ...
Posted by Michael Wonder on 04 Jul 2019
RedHill Biopharma announces FDA acceptance of new drug application for Talicia
3 July 2019 - U.S. FDA accepts NDA for priority review. ...
Posted by Michael Wonder on 03 Jul 2019
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 ...
Posted by Michael Wonder on 02 Jul 2019
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 ...
Posted by Michael Wonder on 01 Jul 2019
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 ...
Posted by Michael Wonder on 29 Jun 2019
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, ...