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RSS FeedPosted 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
BBOT granted US FDA fast track designation for BBO-11818 for the treatment of adult patients with advanced KRAS mutant pancreatic ductal adenocarcinoma
20 April 2026 - BridgeBio Oncology Therapeutics today announced that the US FDA has granted fast track designation to BBO-11818 for ...
Posted by Michael Wonder on 21 Apr 2026
FDA approves Merck’s once daily Idvynso (doravirine/islatravir)
21 April 2026 - Idvynso is the first and only non-INSTI, tenofovir free, once daily, complete two drug regimen to ...
Posted by Michael Wonder on 21 Apr 2026
FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each with Padcev (enfortumab vedotin-ejfv), for cisplatin-eligible patients with muscle invasive bladder cancer
20 April 2026 - Merck today announced that the US FDA granted priority review for two supplemental biologics license applications for ...
Posted 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 ...