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RSS FeedPosted by Michael Wonder on 30 Oct 2023
bluebird bio enters into advance agreement to sell priority review voucher, if granted, for $103 million
30 October 2023 - bluebird bio today announced that it has entered into an agreement to sell a rare paediatric disease ...
Posted by Michael Wonder on 24 Oct 2023
Immatics receives FDA regenerative medicine advanced therapy designation for ACTengine IMA203 TCR-T monotherapy
24 October 2023 - Regulatory activities underway with an initial focus on a registration directed trial in melanoma as step ...
Posted by Michael Wonder on 17 Oct 2023
NorthSea Therapeutics receives FDA rare paediatric disease designation for SEFA-6179 for the treatment of intestinal failure-associated liver disease
17 October 2023 - Rare paediatric disease designation underscores critical need for novel therapies to address IFALD. ...
Posted by Michael Wonder on 16 Oct 2023
Editas Medicine granted FDA regenerative medicine advanced therapy designation for EDIT-301 for the treatment of severe sickle cell disease
16 October 2023 - Editas Medicine today announced that the US FDA granted regenerative medicine advanced therapy designation to EDIT-301, an ...
Posted by Michael Wonder on 16 Oct 2023
Tagrisso plus chemotherapy granted priority review in the US for patients with EGFR mutated advanced lung cancer
16 October 2023 - Decision based on FLAURA2 Phase 3 trial results which extended median progression-free survival by nearly 9 ...
Posted by Michael Wonder on 07 Oct 2023
Zatolmilast, an investigational treatment for Fragile X syndrome, receives rare paediatric disease designation from the US FDA
27 September 2023 - Shionogi announced the US FDA has granted Tetra Therapeutics, a Shionogi Group Company, rare paediatric disease designation ...
Posted 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 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 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 ...