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RSS FeedPosted by Michael Wonder on 18 Dec 2023
AnHeart Therapeutics and Innovent Announce China’s NMPA has granted taletrectinib (ROS1 inhibitor) priority review designation
18 December 2023 -AnHeart Therapeutics and Innovent Biologics today announced the Center for Drug Evaluation of China’s National Medical Products ...
Posted by Michael Wonder on 18 Dec 2023
US FDA issues complete response letter for cosibelimab solely due to inspection findings at third party manufacturer
18 December 2023 - FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability ...
Posted by Michael Wonder on 15 Dec 2023
CymaBay submits new drug application to FDA for seladelpar for the treatment of primary biliary cholangitis
15 December 2023 - New drug application is supported by data evaluating seladelpar efficacy and safety in over 500 patients. ...
Posted by Michael Wonder on 15 Dec 2023
CSL's garadacimab, a first in class factor XIIa inhibitor, receives FDA and EMA filing acceptance
14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with ...
Posted by Michael Wonder on 14 Dec 2023
FDA grants priority review to Amgen's tarlatamab application for advanced small cell lung cancer
13 December 2023 - FDA target action date is 12 June 2024. ...
Posted by Michael Wonder on 13 Dec 2023
Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk
12 December 2023 - Submission supported by positive results of a Phase 3 study showing immune response and safety in adults ...
Posted by Michael Wonder on 13 Dec 2023
MAPS PBC announces submission of new drug application to the FDA for MDMA assisted therapy for PTSD
12 December 2023 - Filing marks first NDA submission for any psychedelic-assisted therapy. ...
Posted by Michael Wonder on 12 Dec 2023
Humacyte submits biologics license application to US FDA seeking approval of human acellular vessel for the treatment of vascular trauma
12 December 2023 - BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the human ...
Posted by Michael Wonder on 12 Dec 2023
FDA and EMA accept marstacimab regulatory submissions for the treatment of haemophilia A and B
11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend ...
Posted by Michael Wonder on 11 Dec 2023
FDA accepts for review resubmitted NDA for TransCon PTH (palopegteriparatide) in adult patients with hypoparathyroidism
11 December 2023 - PDUFA goal date is 14 May 2024. ...
Posted by Michael Wonder on 08 Dec 2023
Phathom Pharmaceuticals announces FDA acceptance for filing of Voquenza (vonoprazan) tablets new drug application for the treatment of heartburn associated with non-erosive GERD
6 December 2023 - July 19, 2024 PDUFA target action date assigned by the FDA. ...
Posted by Michael Wonder on 08 Dec 2023
Adaptimmune completes submission of rolling biologics license application to US FDA for afami-cel for the treatment of advanced synovial sarcoma
6 December 2023 - First BLA for an engineered T-cell therapy for solid tumours submitted to US FDA. ...
Posted by Michael Wonder on 08 Dec 2023
Alpha Cognition announces FDA acceptance of new drug application for ALPHA-1062 for mild to moderate Alzheimer’s disease
7 December 2023 - Alpha Cognition is pleased to announce that the US FDA has completed its filing review and has ...
Posted by Michael Wonder on 07 Dec 2023
Ipsen confirms US FDA grants priority review for new drug application for elafibranor for the treatment of rare cholestatic liver disease, PBC
7 December 2023 - New drug application granted priority review with PDUFA date set for 10 June 2024. ...
Posted by Michael Wonder on 06 Dec 2023
BridgeBio Pharma announces submission of new drug application to US FDA for acoramidis for the treatment of patients with transthyretin amyloid cardiomyopathy
5 December 2023 - NDA submission is based on positive results from ATTRibute-CM Phase 3 study. ...