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RSS FeedPosted by Michael Wonder on 16 Sep 2021
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
Posted by Michael Wonder on 15 Sep 2021
ObsEva announces submission of new drug application to U.S. FDA for linzagolix for the treatment of uterine fibroids
15 September 2021 - NDA submission includes positive data from Phase 3 PRIMROSE trials up to 52 weeks on treatment and ...
Posted by Michael Wonder on 15 Sep 2021
PDUFA goal date extension for Nefecon NDA in the U.S.
14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its ...
Posted by Michael Wonder on 14 Sep 2021
Axsome Therapeutics announces FDA acceptance of new drug application for AXS-07 for the acute treatment of migraine
14 September 2021 - Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s new drug application ...
Posted by Michael Wonder on 14 Sep 2021
Alnylam submits marketing authorisation application to the European Medicines Agency for investigational vutrisiran for the treatment of hereditary ATTR amyloidosis with polyneuropathy
13 September 2021 - If approved, vutrisiran will provide a new, subcutaneously administered, once quarterly treatment option for patients with hATTR ...
Posted by Michael Wonder on 14 Sep 2021
Mirum Pharmaceuticals submits European marketing authorisation application for maralixibat in Alagille syndrome supported by new positive results from natural history study comparison
13 September 2021 - Natural history analysis shows significant improvement in event-free survival and transplant-free survival. ...
Posted by Michael Wonder on 13 Sep 2021
BeiGene announces U.S. FDA acceptance of biologics license application for tislelizumab in oesophageal squamous cell carcinoma
13 September 2021 - This marks the first ex-China regulatory filing for tislelizumab, following approval in five indications in China. ...
Posted by Michael Wonder on 09 Sep 2021
Myovant Sciences and Pfizer announce FDA acceptance of supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
9 September 2021 - FDA PDUFA target action date is 6 May 2022. ...
Posted by Michael Wonder on 08 Sep 2021
Phathom Pharmaceuticals submits two NDAs to U.S. FDA for vonoprazan-based treatment regimens for the treatment of H. pylori infection
8 September 2021 - Phathom Pharmaceuticals announced today that it has submitted two new drug applications to the U.S. FDA for ...
Posted by Michael Wonder on 07 Sep 2021
U.S. FDA accepts for priority review supplemental new drug application for Oxbryta (voxelotor) for the treatment of sickle cell disease in children ages 4 to 11
7 September 2021 - New drug application for Oxbryta dispersible tablets also accepted for priority review. ...
Posted by Michael Wonder on 06 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...
Posted by Michael Wonder on 05 Sep 2021
CStone announces China's NMPA has accepted its new drug application for sugemalimab in the treatment of stage III NSCLC
2 September 2021 - Sugemalimab becomes the world’s first anti-PD-1/PD-L1 monoclonal antibody to significantly improve progression-free survival in patients with stage ...
Posted by Michael Wonder on 05 Sep 2021
Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster
3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...
Posted by Michael Wonder on 03 Sep 2021
FDA acceptance for filing of new drug application for trientine tetrahydrochloride for the treatment of Wilson’s disease
2 September 2021 - New drug application supported by positive data from Phase 3 CHELATE clinical trial. ...
Posted by Michael Wonder on 02 Sep 2021
Moderna announces submission of initial data to U.S. FDA for its COVID-19 vaccine booster
1 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40x against the ...