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RSS FeedPosted 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. ...
Posted by Michael Wonder on 02 Sep 2019
Genentech provides update on supplemental biologics licence application for Tecentriq in first-line metastatic non-squamous non-small cell lung cancer
30 August 2019 - Genentech was notified by the U.S. FDA that the review period for the supplemental biologics license application ...
Posted by Michael Wonder on 27 Aug 2019
Viela Bio announces U.S. FDA accepts for review inebilizumab biologics license application for neuromyelitis optica spectrum disorder
27 August 2019 - U.S. FDA accepts for review Viela Bio's first BLA filing. ...
Posted by Michael Wonder on 21 Aug 2019
BeiGene announces U.S. FDA acceptance and grant of priority review for its new drug application of zanubrutinib in patients with relapsed/refractory Mantle cell lymphoma
21 August 2019 - BeiGene today announced that the U.S. FDA has accepted the company’s new drug application for zanubrutinib for ...
Posted by Michael Wonder on 21 Aug 2019
Cassiopea announces FDA submission of new drug application for clascoterone 1% cream, the first new mechanism of action for acne in nearly 40 years
20 August 2019 - Cassiopea announced today that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 20 Aug 2019
FDA accepts new drug application for VX-445 (elexacaftor), tezacaftor and ivacaftor combination treatment
20 August 2019 - FDA grants priority review of the application and sets a PDUFA target action date of 19 ...
Posted by Michael Wonder on 20 Aug 2019
Vanda Pharmaceuticals FDA update for Hetlioz in the treatment of jet lag disorder
19 August 2019 - Vanda Pharmaceuticals today announced that on 16 August 2019, it received a complete response letter from ...
Posted by Michael Wonder on 17 Aug 2019
As Sarepta awaits approval of new Duchenne drug, big questions hang over therapy already on market
15 August 2019 - As Sarepta Therapeutics waits for the FDA to announce an approval decision on a new drug ...
Posted by Michael Wonder on 15 Aug 2019
Growing numbers of priority and competitive ANDAs under review as approvals trickle in
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic ...