Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 06 Jun 2025
Sydnexis announces European Commission approval of SYD-101, the first and only pharmaceutical treatment for slowing the progression of paediatric myopia
5 June 2025 - Exclusive licensing partner Santen will commercialise SYD-101 under the brand name Ryjunea in the EU. ...
Posted by Michael Wonder on 05 Jun 2025
Linerixibat new drug application accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis
2 June 2025 - GSK today announced the US FDA has accepted for review the new drug application for linerixibat, an ...
Posted by Michael Wonder on 05 Jun 2025
TGA approves weight loss drug to treat sleep disorder
4 June 2025 - The country’s medicines regulator has approved the use of a GLP-1 weight-loss drug to treat people ...
Posted by Michael Wonder on 05 Jun 2025
Roche’s Evrysdi tablet approved by European Commission as first and only for spinal muscular atrophy
4 June 2025 - Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with ...
Posted by Michael Wonder on 04 Jun 2025
Chimeric Therapeutics CDH17 receives FDA fast track
4 June 2025 - Chimeric Therapeutics is pleased to announce that the US FDA has granted CHM CDH17 fast track ...
Posted by Michael Wonder on 04 Jun 2025
Cellectar granted US FDA breakthrough therapy designation for iopofosine I 131 in Waldenstrom macroglobulinemia
4 June 2025 - Designation supported by CLOVER WaM Phase 2 study data which reported an 83.6% overall response rate. ...
Posted by Michael Wonder on 04 Jun 2025
MHRA approves aumolertinib to treat non-small cell lung cancer
3 June 2025 - The MHRA has approved aumolertinib (Aumseqa) for adult patients with non-small cell lung cancer. ...
Posted by Michael Wonder on 04 Jun 2025
DoH publishes revised agenda for May 2025 PBAC meeting in June!
4 June 2025 - The DoH has published a revised agenda for last month's PBAC meeting. ...
Posted by Michael Wonder on 03 Jun 2025
Pheast Therapeutics receives FDA fast track designation for PHST001 for the treatment of ovarian cancer
3 June 2025 - Pheast Therapeutics today announced that the US FDA has granted fast track designation to PHST001 for ...
Posted by Michael Wonder on 03 Jun 2025
Amylyx Pharmaceuticals receives US FDA fast track designation for AMX0114 for the treatment of amyotrophic lateral sclerosis
3 June 2025 - AMX0114 is an Amylyx developed antisense oligonucleotide designed to target calpain-2, a key contributor to the ...
Posted by Michael Wonder on 03 Jun 2025
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with newly diagnosed stage IIb/III/IV Hodgkin lymphoma in combination with ECADD
3 June 2025 - Approval based on positive results from the Phase 3 HD21 trial for stage IIb with risk factors/III/IV ...
Posted by Michael Wonder on 03 Jun 2025
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
3 June 2025 - Today, the FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC). ...
Posted by Michael Wonder on 03 Jun 2025
Ipsen’s Cabometyx kidney cancer reimbursement bid collapses in Korea after price talks fail
30 May 2025 - Ipsen Korea’s months-long effort to expand reimbursement for Cabometyx (cabozantinib) has ended in failure, cutting off ...
Posted by Michael Wonder on 03 Jun 2025
MaaT Pharma submits marketing authorisation application to the EMA for Xervyteg (MaaT013) in acute graft versus host disease
2 June 2025 - The marketing authorisation application submitted to the EMA is based on data from the Pivotal ARES study, evaluating ...
Posted by Michael Wonder on 03 Jun 2025
Zealand Pharma submits marketing authorisation application to the EMA for glepaglutide in short bowel syndrome
2 June 2025 - Zealand Pharma today announced the submission of a marketing authorisation application to the EMA for glepaglutide, ...