Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 22 Apr 2026
4Moving Biotech granted FDA fast track designation to 4P004, supporting an accelerated development pathway in knee osteoarthritis
22 April 2026 - 4Moving Biotech today announced that the US FDA has granted fast track designation to 4P004 for the ...
Posted by Michael Wonder on 22 Apr 2026
New life-extending treatment given the green light for people with rare form of bile duct cancer
21 April 2026 - A new targeted treatment for a rare and aggressive form of bile duct cancer has been recommended ...
Posted by Michael Wonder on 22 Apr 2026
Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children
22 April 2026 - The US FDA has approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication ...
Posted by Michael Wonder on 22 Apr 2026
Dupixent (dupilumab) approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria
22 April 2026 - Approval for children aged 2 to 11 years with chronic spontaneous urticaria who remain symptomatic despite H1 ...
Posted by Michael Wonder on 22 Apr 2026
Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US
22 April 2026 - The US FDA has extended by up to three months the target action date for its review ...
Posted by Michael Wonder on 22 Apr 2026
Southern NSW family's push for affordable eczema medication so kids can have a normal childhood
22 April 2026 - Playing rugby league with his friends is one of Tanner Hosie's favourite things to do, but ...
Posted by Michael Wonder on 22 Apr 2026
Biocon receives Health Canada approval of Bosaya (denosumab) and Vevzuo (denosumab), biosimilars to Prolia and Xgeva
21 April 2026 - Biocon is pleased to announce that Health Canada has granted a Notice of Compliance for Bosaya (denosumab), ...
Posted by Michael Wonder on 22 Apr 2026
Moderna receives European Commission marketing authorisation for mCOMBRIAX, Moderna's mRNA combination vaccine against influenza and COVID-19
21 April 2026 - mCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures ...
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
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
European Commission approves Merck’s Enflonsia (clesrovimab) for the prevention of respiratory syncytial virus lower respiratory tract disease in infants during their first RSV season
17 April 2026 - Merck announced today that the European Commission has approved Enflonsia (clesrovimab) for the prevention of respiratory syncytial ...
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 ...