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RSS FeedPosted 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 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
ICER releases white paper on accelerated approval pathway for prescription drugs
16 April 2026 - The ICER, in collaboration with Verdant Research, has published a new white paper today that examines the ...
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
CMS proposes rolling back breakthrough device payment flexibilities
15 April 2026 - The agency wants these devices to show meaningful improvement over existing alternatives. ...
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 ...