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RSS FeedPosted by Michael Wonder on 23 Apr 2026
Debiopharm announces FDA fast track designation for lunresertib in combination with zedoresertib for genomic defined platinum-resistant ovarian cancer
23 April 2026 - Debiopharm today announced that the US FDA has granted fast track designation to the combination of its ...
Posted by Michael Wonder on 23 Apr 2026
Polaryx Therapeutics receives US FDA fast track designations for all four indications to be evaluated in the SOTERIA basket trial
21 April 2026 - Polaryx Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
Posted by Michael Wonder on 23 Apr 2026
Enflonsia (clesrovimab-cfor) approved to prevent RSV in newborns and infants
22 April 2026 - The MHRA has today approved the medicine Enflonsia (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) ...
Posted by Michael Wonder on 23 Apr 2026
Regeneron announces agreement with US Government to help lower drug costs for American patients and will provide innovative new gene therapy for free in the US
23 April 2026 - Regeneron Pharmaceuticals today announced an agreement with the US Government to help lower prices of several ...
Posted by Michael Wonder on 23 Apr 2026
AbbVie provides update on trenibotulinumtoxinE (TrenibotE) biologics license application in the US
23 April 2026 - AbbVie today announced that it received a complete response letter from the US FDA regarding the ...
Posted by Michael Wonder on 23 Apr 2026
EMA publishes agenda for 20-23 April 2026 CHMP meeting
20 April 2026 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Apr 2026
Ojemda approved in the European Union as the first targeted therapy in relapsed or refractory pediatric low-grade glioma regardless of BRAF alteration
22 April 2026 - Approval is based on pivotal Phase 2 FIREFLY-1 data demonstrating meaningful and durable tumour responses. ...
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 ...