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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 May 2026
Satellite Bio announces FDA rare paediatric disease designation for SB-101 for the treatment of urea cycle disorders
4 May 2026 - Satellite Biosciences today announced that the US FDA has granted rare paediatric disease designation for SB-101 for ...
Posted by Michael Wonder on 05 May 2026
Atossa Therapeutics receives FDA rare paediatric disease designation for (Z)-endoxifen for McCune-Albright syndrome
4 May 2026 - Atossa Therapeutics today announced that the US FDA has granted rare paediatric disease designation to (Z)-endoxifen for ...
Posted by Michael Wonder on 30 Apr 2026
US FDA grants priority review to BeOne Medicines’ Tevimbra in first-line HER2 positive gastro-oesophageal adenocarcinoma
29 April 2026 - BeOne Medicines today announced that the US FDA has granted priority review to a supplemental biologics ...
Posted by Michael Wonder on 30 Apr 2026
Expression Therapeutics receives FDA fast track and rare paediatric disease designations for investigational stem cell therapy for haemophilia A
29 April 2026 - Expression Therapeutics today announced that the US FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 28 Apr 2026
FDA grants priority review for Imavvy (nipocalimab-aahu) as the potential first approved treatment for people living with warm auto-immune haemolytic anaemia
27 April 2026 - Johnson & Johnson announced today that the US FDA has granted priority review to the supplemental biologics ...
Posted by Michael Wonder on 28 Apr 2026
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental biologics license application for Ziihera (zanidatamab-hrii) combinations in first-line HER2 positive locally advanced or metastatic gastric cancer
27 April 2026 - Jazz Pharmaceuticals today announced that the US FDA accepted for filing with priority review the supplemental biologics ...
Posted by Michael Wonder on 28 Apr 2026
GSK’s investigational liver therapy, efimosfermin, receives US FDA breakthrough therapy and EMA Priority Medicines (PRIME) designations for MASH
27 April 2026 - GSK today announced that efimosfermin, a once monthly investigational liver therapy, has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 25 Apr 2026
FDA accelerates action on treatments for serious mental illness following executive order
24 April 2026 - Agency issues priority vouchers, clears new clinical research, and advances guidance to support treatments for depression, PTSD, ...
Posted by Michael Wonder on 22 Apr 2026
Star Therapeutics receives FDA rare paediatric disease and breakthrough therapy designations for VGA039 in von Willebrand disease prophylaxis
21 April 2026 - VGA039 is a once monthly, subcutaneously self-administered investigational therapy for the treatment of bleeding disorders, initially being ...
Posted by Michael Wonder on 21 Apr 2026
20 years of priority review vouchers, a tool for spurring needed drugs
19 April 2026 - Occasionally I’ll go watch a TV show taping. Big-name shows are sold out, with long lines ...