Blog
RSS FeedPosted by Michael Wonder on 29 Apr 2022
Fennec Pharmaceuticals announces FDA acceptance for filing of new drug application resubmission for Pedmark
27 April 2022 - Prescription Drug User Fee Act target action date set for 23 September 2022. ...
Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children. ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and BioNTech submit application for U.S. emergency use authorisation for a COVID-19 vaccine booster dose in children 5 through 11 years of age
26 April 2022 - Pfizer and BioNTech today submitted an application to the U.S. Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 25 Apr 2022
Tremelimumab accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi
25 April 2022 - STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual ...
Posted by Michael Wonder on 23 Apr 2022
Medexus Pharmaceuticals announces resubmission of treosulfan NDA
22 April 2022 - Additional data collection and analysis reconfirms confidence in new drug application for treosulfan. ...
Posted by Michael Wonder on 21 Apr 2022
Revance receives FDA acceptance of BLA resubmission for daxibotulinumtoxinA for injection for glabellar lines
21 April 2022 - PDUFA goal date set for 8 September 2022. ...
Posted by Michael Wonder on 20 Apr 2022
New drug application resubmission update
20 April 2022 - Polarean Imaging announces that further to the RNS issued on 31 March 2022, the Company can confirm ...
Posted by Michael Wonder on 20 Apr 2022
Teva and MedinCell receive complete response letter for TV-46000/mdc-IRM
19 April 2022 - Teva Pharmaceuticals and MedinCell announced that the U.S. FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 19 Apr 2022
US Food and Drug Administration accepts new drug application for daprodustat
19 April 2022 - Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase 3 ...
Posted by Michael Wonder on 19 Apr 2022
Enhertu granted priority review in the U.S. for patients with previously treated HER2 mutant metastatic non-small-cell lung cancer
19 April 2022 - Based on pivotal DESTINY-Lung01 results showing Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a 54.9% tumour response ...
Posted by Michael Wonder on 15 Apr 2022
TG Therapeutics announces voluntary withdrawal of the BLA/sNDA for U2 to treat patients with CLL and SLL
15 April 2022 - TG Therapeutics today announced that the Company has voluntarily withdrawn the pending biologics license application/supplemental new drug ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
Posted by Michael Wonder on 12 Apr 2022
Myovant Sciences and Pfizer provide update on supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
12 April 2022 - Myovant Sciences and Pfizer announced today an update on the Supplemental new drug application for Myfembree ...
Posted by Michael Wonder on 12 Apr 2022
Aeglea BioTherapeutics submits BLA to FDA for pegzilarginase for the treatment of arginase 1 deficiency
12 April 2022 - European marketing application on track for submission this year. ...
Posted by Michael Wonder on 11 Apr 2022
Spectrum Pharmaceuticals announces FDA acceptance of BLA resubmission for eflapegrastim
11 April 2022 - FDA has assigned 9 September 2022 as the PDUFA date. ...