Blog
RSS FeedPosted by Michael Wonder on 24 Jan 2024
US FDA seeks 'boxed warning' for CAR-T cancer therapies
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...
Posted by Michael Wonder on 24 Jan 2024
UroGen initiates submission of a rolling NDA to the FDA for UGN-102
24 January 2024 - UroGen Pharma today announced the submission of the Chemistry, Manufacturing, and Controls section of the new drug ...
Posted by Michael Wonder on 24 Jan 2024
Heron Therapeutics announces FDA approval of Zynrelef indication expansion to include additional orthopaedic and soft tissue procedures
23 January 2024 - Expanded indication for Zynrelef now covers approximately 13 million procedures annually. ...
Posted by Michael Wonder on 23 Jan 2024
Theratechnologies receives update from FDA on tesamorelin F8 supplemental biologics license application
23 January 2024 - FDA continues to review the file past the Prescription Drug User Fee Act goal date of ...
Posted by Michael Wonder on 23 Jan 2024
4DMT receives rare paediatric disease designation from FDA for aerosolised 4D-710 for treatment of cystic fibrosis lung disease
23 January 2024 - Interim data update from Phase 1/2 AEROW clinical trial expected in mid-2024, and pivotal trial planning ...
Posted by Michael Wonder on 23 Jan 2024
Ensysce Biosciences announces FDA breakthrough therapy designation granted for PF614-MPAR
23 January 2024 - FDA acknowledges significant potential impact of MPAR's oral overdose protection. ...
Posted by Michael Wonder on 23 Jan 2024
Autolus Therapeutics announces acceptance of biologics license application for obecabtagene autoleucel as a potential treatment for relapsed/refractory adult B-cell acute lymphoblastic leukaemia
22 January 2024 - PDUFA goal date is 16 November 2024. ...
Posted by Michael Wonder on 22 Jan 2024
Botannix Pharmaceuticals’ resubmission of Sofdra NDA accepted by FDA
22 January 2024 - Botannix Pharmaceuticals’ resubmission of the new drug application for Sofdra has been accepted by the FDA ...
Posted by Michael Wonder on 19 Jan 2024
FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma
19 January 2024 - Today, the FDA approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic ...
Posted by Michael Wonder on 19 Jan 2024
Kyverna Therapeutics granted FDA fast track designation for KYV-101 in the treatment of patients with refractory progressive multiple sclerosis
19 January 2024 - The announcement follows the recent IND clearance for KYV-101 to be used in Kyverna's KYSA-7 Phase 2 ...
Posted by Michael Wonder on 19 Jan 2024
US FDA grants mesoblast rare paediatric disease designation for Revascor (Rexlemestrocel-L) in children with congenital heart disease
19 January 2024 - Revascor increases size of left heart chamber and improves surgical outcomes in children with hypoplastic left ...
Posted by Michael Wonder on 18 Jan 2024
Verastem Oncology granted fast track designation for combination of avutometinib and sotorasib for the treatment of KRAS G12C mutant non-small-cell lung cancer
18 January 2024 - On-going RAMP 203 trial assessing a more complete vertical blockade with RAF/MEK and KRAS G12C inhibition along ...
Posted by Michael Wonder on 18 Jan 2024
UtilityTherapeutics announces FDA acceptance of PIVYA new drug application with priority review
17 January 2024 - Utility has received a Prescription Drug User Fee Act target action date of 24 April 2024. ...
Posted by Michael Wonder on 18 Jan 2024
US FDA declines to approve Shin Nippon Biomedical's migraine drug
17 January 2024 - The US health regulator has declined to approve Japan-based Shin Nippon Biomedical Laboratories' treatment for acute ...
Posted by Michael Wonder on 17 Jan 2024
Dupixent (dupilumab) US label updated with data further supporting use in atopic dermatitis with moderate to severe hand and foot involvement
16 January 2024 - Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult to ...