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RSS FeedPosted by Michael Wonder on 21 Apr 2026
FDA accepts application for Genentech’s Gazyva for the treatment of the most common form of lupus
20 April 2026 - Filing acceptance based on Phase 3 ALLEGORY data for Gazyva showing a significant reduction in disease activity ...
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 ...
Posted by Michael Wonder on 21 Apr 2026
First FDA approved treatment for patients with focal segmental glomerulosclerosis—a rare kidney condition
16 April 2026 - The US FDA on Monday approved a new indication for Filspari (sparsentan) tablets for reducing proteinuria in ...
Posted by Michael Wonder on 21 Apr 2026
US FDA grants priority review to sBLA for Padcev and Keytruda as peri-operative treatment for muscle invasive bladder cancer regardless of cisplatin eligibility
20 April 2026 - Astellas Pharma and Pfizer announced that the US FDA accepted for triority review a supplemental biologics license ...
Posted by Michael Wonder on 20 Apr 2026
President Donald J. Trump is accelerating medical treatments for serious mental illness
18 April 2026 - Today, President Donald J. Trump signed an Executive Order that will accelerate access to treatments for patients ...
Posted by Michael Wonder on 19 Apr 2026
Aicuris receives FDA priority review for pritelivir NDA
16 April 2026 - 26 - Aicuris Anti-infective Cures today announced that the US FDA has granted priority review for the ...
Posted by Michael Wonder on 17 Apr 2026
Medera receives FDA fast track designation for gene therapy targeting Duchenne muscular dystrophy associated cardiomyopathy
16 April 2026 - Medera today announced that the US FDA has granted fast track designation to AAV-SERCA2a, an investigational ...
Posted by Michael Wonder on 16 Apr 2026
Savara announces the US FDA has extended the review period for the molgramostim inhalation solution biologics license application in autoimmune pulmonary alveolar proteinosis
15 April 2026 - Savara today announced that the FDA has extended the review period for the molgramostim BLA in ...
Posted by Michael Wonder on 16 Apr 2026
Opna Bio announces fast track designation granted to OPN-6602 for the treatment of multiple myeloma
15 April 2026 - Opna Bio today announced that the US FDA has granted fast track designation to OPN-6602, a dual ...
Posted by Michael Wonder on 16 Apr 2026
Arbutus receives US FDA fast track designation for imdusiran for the treatment of chronic hepatitis B
15 April 2026 - Arbutus Biopharma today announced that the US FDA has granted fast track designation for imdusiran for the ...
Posted by Michael Wonder on 15 Apr 2026
Partner Therapeutics announces submission of supplemental biologics license application to FDA for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
14 April 2026 - Partner Therapeutics announces the submission of a supplemental biologics license application to the US FDA for Bizengri ...
Posted by Michael Wonder on 15 Apr 2026
Aligos Therapeutics announces first interim analysis results from the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection and grant of FDA fast track designation
14 April 2026 - Aligos Therapeutics today announced the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir ...
Posted by Michael Wonder on 15 Apr 2026
Praxis Precision Medicines announces FDA acceptance of new drug application for ulixacaltamide hydrochloride in patients with essential tremor
14 April 2026 - - Praxis Precision Medicines today announced that the US FDA has accepted for review its new drug ...
Posted by Michael Wonder on 15 Apr 2026
My brother can’t access a just approved breakthrough drug for his rare disease
14 April 2026 - A new therapy for Hunter syndrome highlights the inequities of age-based approvals. ...
Posted by Michael Wonder on 15 Apr 2026
Renaissance Pharma secures FDA fast track designation for daretabart (hu1418K322A) in high risk neuroblastoma
14 April 2026 - Renaissance Pharma Limited, an Essential Pharma company, today announces that the US FDA has granted fast track ...