Blog
RSS FeedPosted by Michael Wonder on 08 Jul 2026
US FDA grants priority review to Agios’ sNDA for mitapivat in sickle cell disease
7 July 2026 - Agios Pharmaceuticals today announced that the US FDA has accepted its supplemental new drug application for mitapivat, ...
Posted by Michael Wonder on 02 Jul 2026
FDA grants priority review to Roche’s Enspryng, the first and only at home subcutaneous treatment option for thyroid eye disease
30 June 2026 - Roche announced today that the US FDA has accepted and granted priority review to a supplemental biologics ...
Posted by Michael Wonder on 23 Jun 2026
Prime Medicine receives US FDA regenerative medicine advanced therapy designation for PM359 for the treatment of chronic granulomatous disease
22 June 2026 - Prime Medicine today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 15 Jun 2026
US FDA grants orphan drug and rare paediatric disease designations to GEn1E Lifesciences’ dual signal modulator for the treatment of Duchenne muscular dystrophy
9 June 2026 - GEn1E Lifesciences today announced that the US FDA has granted both orphan drug designation and rare paediatric ...
Posted by Michael Wonder on 15 Jun 2026
Ultomiris granted priority review in the US as treatment for adults with immunoglobulin A nephropathy
15 June 2026 - Based on I CAN Phase 3 trial results from prespecified interim analysis in which Ultomiris demonstrated 43.4% ...
Posted by Michael Wonder on 12 Jun 2026
FDA grants priority review for Genentech’s Tecentriq for a certain type of stage III colon cancer
10 June 2026 - Genentech announced today that the US FDA has accepted the company’s supplemental biologics license application filing for ...
Posted by Michael Wonder on 10 Jun 2026
RedHill's opaganib receives FDA rare paediatric disease designation for neuroblastoma in addition to current orphan drug designation
9 June 2026 - RedHill Biopharma today announced that the US FDA has granted rare pediatric disease designation to opaganib for ...
Posted by Michael Wonder on 02 Jun 2026
US FDA accepts for priority review Bristol Myers Squibb’s supplemental new drug application for Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic Cardiomyopathy
1 June 2026 - Bristol Myers Squibb today announced the US FDA accepted a supplemental new drug application for Camzyos ...
Posted by Michael Wonder on 29 May 2026
Zydus Therapeutics new drug application for saroglitazar to treat primary biliary cholangitis granted priority review by the US FDA
28 May 2026 - Zydus Therapeutics today announced that the US FDA granted priority review to the new drug application ...
Posted by Michael Wonder on 29 May 2026
Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease
28 May 2026 - The US FDA has granted priority review to the new drug application for venglustat, a novel, ...
Posted by Michael Wonder on 20 May 2026
FDA accepts sNDA and grants priority review to Aqneursa for ataxia-telangiectasia
19 May 2026 - IntraBio today announced that the US FDA has accepted for review its supplemental new drug application ...
Posted by Michael Wonder on 19 May 2026
Bayer granted priority review by US FDA for asundexian in patients after a non-cardioembolic ischaemic stroke or transient ischaemic attack
19 May 2026 - Bayer today announced that the US FDA has accepted the company’s new drug application and granted priority ...
Posted by Michael Wonder on 18 May 2026
US FDA grants priority review to supplemental new drug application for Hyrnuo (sevabertinib) under investigation as a first-line treatment of HER2 mutated non-small cell lung cancer
18 May 2026 - Regulatory submission for first-line use of Hyrnuo is based on results from the on-going Phase I/II SOHO-01 ...
Posted by Michael Wonder on 08 May 2026
Rznomics announces US FDA regenerative medicine advanced therapy designation granted to RZ-001 for hepatocellular carcinoma
8 May 2026 - RMAT designation based on promising Phase 1b/2a clinical data, including safety profile and preliminary response rates, ...
Posted by Michael Wonder on 07 May 2026
Partner Therapeutics announces receipt of FDA Commissioner's National Priority Voucher for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
6 May 2026 - Partner Therapeutics today announced that the US FDA has awarded a Commissioner's National Priority Voucher pilot program ...