Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2023
FDA accepts for priority review Merck’s supplemental new drug application for Welireg (belzutifan) in certain previously treated patients with advanced renal cell carcinoma
19 September 2023 - Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically ...
Posted by Michael Wonder on 19 Sep 2023
Orchard Therapeutics announces acceptance of biologics license application for OTL-200 in MLD and receives priority review
18 September 2023 - PDUFA date set for 18 March 2024. ...
Posted by Michael Wonder on 13 Sep 2023
Madrigal Pharmaceuticals announces NDA acceptance and priority review of the new drug application for resmetirom for the treatment of NASH with liver fibrosis
13 September 2023 - Madrigal Pharmaceuticals today announced that the US FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 31 Aug 2023
Zealand Pharma announces designation of priority review by the US FDA for dasiglucagon in congenital hyperinsulinism
30 August 2023 - To ensure the most efficient regulatory process, the review by the US FDA will be conducted in ...
Posted by Michael Wonder on 30 Aug 2023
Bloomsbury Genetic Therapies receives rare paediatric disease designation from the US FDA for BGT-INAD for the treatment of infantile neuroaxonal dystrophy
29 August 2023 - Bloomsbury Genetic Therapies Limited announced today that the US FDA has granted rare paediatric disease designation for ...
Posted by Michael Wonder on 23 Aug 2023
FDA grants priority review for Xtandi in non-metastatic castration sensitive prostate cancer with high risk biochemical recurrence
23 August 2023 - If approved, Xtandi would become the first and only novel hormone therapy approved in this earlier ...
Posted by Michael Wonder on 22 Aug 2023
Krystal Biotech announces sale of priority review voucher for $100 million
21 August 2023 - Krystal Biotech announced that it has completed the sale of its rare paediatric disease priority review ...
Posted by Michael Wonder on 18 Aug 2023
FDA grants priority review for full approval of Tarpeyo for the treatment of IgA nephropathy
18 August 2023 - Calliditas Therapeutics today announced that the US FDA has accepted the submission for the supplemental new ...
Posted by Michael Wonder on 16 Aug 2023
Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in the treatment of IDH1 mutated relapsed or refractory myelodysplastic syndromes
15 August 2023 - Submission supported by comprehensive clinical data package, including updated results that demonstrate durable remissions and an ...
Posted by Michael Wonder on 15 Aug 2023
Lactiga receives FDA rare paediatric disease designation for groundbreaking mucosal immunoglobulin therapy for common variable immunodeficiency disease
14 August 2023 - LCTG-001 on course to be the first FDA approved biologic from human milk. ...
Posted by Michael Wonder on 07 Aug 2023
HuidaGene Therapeutics receives FDA rare paediatric disease designation for HG004 to treat inherited blindness
7 August 2023 - HG004 is a one time, direct to RPE treatment of inherited retinal disease caused by mutations in ...
Posted by Michael Wonder on 03 Aug 2023
Aardvark Therapeutics announces receipt of FDA rare paediatric disease designation for Prader-Willi syndrome
3 August 2023 - Aardvark's Phase 2 trial of oral ARD-101 in young adults with Prader-Willi syndrome is now open ...
Posted by Michael Wonder on 01 Aug 2023
FDA grants QIDP designation for Kinnear's CSA-131 drug for life-threatening Pseudomonas bacterial infections in CF
31 July 2023 - Kinnear Pharmaceuticals today announced the US FDA has granted qualified infectious disease product designation for CSA-131 ...
Posted by Michael Wonder on 20 Jul 2023
Advent Therapeutics receives FDA rare paediatric disease designation for retinol palmitate for prevention of bronchopulmonary dysplasia in premature infants
20 July 2023 - Advent plans FDA PDUFA meeting late 2023 to establish pathway for US approval of lead injectable ...
Posted by Michael Wonder on 13 Jul 2023
Aridis’ AR-301 monoclonal antibody is among the first biologics to receive FDA’s qualified infectious diseases product designation
12 July 2023 - QIDP designation for biologics provides FDA priority review status. ...