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RSS FeedPosted by Michael Wonder on 10 Jun 2024
Tagrisso granted priority review in the US for patients with unresectable, stage III EGFR mutated lung cancer
10 June 2024 - Decision based on LAURA Phase 3 trial results which extended median progression-free survival by more than ...
Posted by Michael Wonder on 06 Jun 2024
BlueRock Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease cell therapy candidate bemdaneprocel
31 May 2024 - Regenerative Medicine Advanced Therapy designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated ...
Posted by Michael Wonder on 06 Jun 2024
Neurogene announces NGN-401 gene therapy for Rett syndrome selected by FDA for START pilot program
3 June 2024 - NGN-401 is one of only three CBER programs chosen by FDA. ...
Posted by Michael Wonder on 06 Jun 2024
Denali Therapeutics announces FDA has selected DNL126 for MPS IIIA (Sanfilippo syndrome type A) for START pilot program intended to accelerate development of rare disease therapies
3 June 2024 - START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further ...
Posted by Michael Wonder on 06 Jun 2024
Moderna's investigational therapeutic for methylmalonic acidaemia (mRNA-3705) selected by US FDA for START pilot program
6 June 2024 - Center for Biologics Evaluation and Research has chosen mRNA-3705 as one of four investigational medicines for ...
Posted by Michael Wonder on 05 Jun 2024
TScan Therapeutics receives FDA’s regenerative medicine advanced therapy designation for its two lead TCR-T therapy candidates for the treatment of heme malignancies
29 May 2024 - RMAT designation granted for both TSC-100 and TSC-101 for the treatment of patients with AML, ALL, and ...
Posted by Michael Wonder on 05 Jun 2024
uniQure receives FDA regenerative medicine advanced therapy designation for investigational gene therapy AMT-130 in Huntington’s disease
3 June 2024 - Designation based on 24 month interim Phase 1/2 clinical data for AMT-130 announced in December 2023. ...
Posted by Michael Wonder on 03 Jun 2024
Zanidatamab granted priority review for HER2 positive metastatic biliary tract cancer
29 May 2024 - Target action (PDUFA) date set for 29 November 2024. ...
Posted by Michael Wonder on 30 May 2024
FDA grants priority review to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
29 May 2024 - The target action date for the FDA decision is 27 November 2024. ...
Posted by Michael Wonder on 29 May 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
29 May 2024 - Acceptance based on results from the pivotal Phase 3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant ...
Posted by Michael Wonder on 23 May 2024
Cartesian Therapeutics receives FDA regenerative medicine advanced therapy designation for Descartes-08 for the treatment of myasthenia gravis
22 May 2024 - Cartesian Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation for ...
Posted by Michael Wonder on 21 May 2024
Wugen announces RMAT and PRIME designations for WU-CART-007 to accelerate regulatory reviews
20 May 2024 - Researchers to present new Phase 2 data showing safety and anti-leukaemic activity with WU-CART-007 and additional new ...
Posted by Michael Wonder on 15 May 2024
PTC Therapeutics announces FDA acceptance and priority review of the BLA for Upstaza
14 May 2024 - PDUFA target action date of 13 November 2024. ...
Posted by Michael Wonder on 13 May 2024
Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of adolescents with chronic rhinosinusitis with nasal polyposis
13 May 2024 - If approved, Dupixent would be the first treatment in the US indicated for adolescents aged 12-17 years ...
Posted by Michael Wonder on 06 May 2024
Merus announces US FDA acceptance and priority review of biologics license application for zenocutuzumab for the treatment of NRG1 positive NSCLC and PDAC
6 May 2024 - If approved, zenocutuzumab will be the first targeted therapy for NRG1 positive cancer. ...