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RSS FeedPosted by Michael Wonder on 03 Oct 2023
Rocket Pharmaceuticals announces FDA acceptance of biologics license application with priority review for RP-L201 (marnetegragene autotemcel) for the treatment of severe leukocyte adhesion deficiency-I
2 October 2023 - PDUFA target action date is 31 March 2024. ...
Posted by Michael Wonder on 29 Sep 2023
Odronextamab BLA for treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma accepted for FDA priority review
29 September 2023 - If approved, odronextamab would be the first and only bispecific antibody approved in both FL and DLBCL ...
Posted by Michael Wonder on 29 Sep 2023
Merck receives priority review from FDA for new biologics license application for sotatercept, an activin signaling inhibitor to treat adults with pulmonary arterial hypertension
28 September 2023 - Application based on clinically meaningful results from the Phase 3 STELLAR trial. ...
Posted by Michael Wonder on 26 Sep 2023
Dupixent (dupilimab) sBLA for treatment of eosinophilic oesophagitis in children aged 1 to 11 accepted for FDA priority review
26 September 2023 - If approved, Dupixent would be the first and only treatment in the US indicated for children aged ...
Posted by Michael Wonder on 25 Sep 2023
Golidocitinib granted priority review by China NMPA for the treatment of relapsed/refractory peripheral T-cell lymphoma
21 September 2023 - Dizal announced today that the China National Medical Products Administration has granted priority review status to golidocitinib, ...
Posted by Michael Wonder on 24 Sep 2023
MicuRx receives FDA qualified infectious disease product and fast track designation for contezolid and contezolid acefosamil
22 September 2023 - MicuRx Pharmaceuticals today announced that the US FDA has granted Qualified Infectious Disease Product and the fast ...
Posted by Michael Wonder on 21 Sep 2023
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus concurrent chemoradiotherapy as treatment for patients with newly diagnosed high risk locally advanced cervical cancer
20 September 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A18 trial, which showed a statistically significant and clinically ...
Posted 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 19 Sep 2023
Cellectar Biosciences receives European Medicines Agency Priority Medicines (PRIME) designation for iopofosine for Waldenstrom’s macroglobulinaemia
18 September 2023 - The EMA’s PRIME status is granted to drug candidates that may offer a major therapeutic advantage over ...
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 ...