Blog
RSS FeedPosted by Michael Wonder on 08 Aug 2025
FDA approves expanded indication for Avtozma (tocilizumab-anoh) intravenous formulation in cytokine release syndrome
6 August 2025 - Approval of Avtozma (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and paediatric patients aged ...
Posted by Michael Wonder on 06 Aug 2025
FDA grants accelerated approval to dordaviprone for diffuse midline glioma
6 August 2025 -Today, the FDA granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and ...
Posted by Michael Wonder on 06 Aug 2025
Kye Pharmaceuticals announces the approval of Dynavel XR (amphetamine extended release) tablets and oral suspension for the treatment of adults and children with ADHD
5 August 2025 - Kye Pharmaceuticals is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel XR ...
Posted by Michael Wonder on 04 Aug 2025
Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by US FDA in fifth cancer type for relapsed or refractory marginal zone lymphoma
4 August 2025 - Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application ...
Posted by Michael Wonder on 02 Aug 2025
Update on US regulatory review of supplemental biologics license application
1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex ...
Posted by Michael Wonder on 01 Aug 2025
Lenz Therapeutics announces US FDA approval of Vizz for the treatment of presbyopia
31 July 2025 - Vizz samples and product availability in the US expected as early as October 2025. ...
Posted by Michael Wonder on 01 Aug 2025
Novartis twice yearly Leqvio (inclisiran) receives FDA approval for new indication enabling first-line use
31 July 2025 - 4 out of 5 atherosclerotic cardiovascular disease patients do not reach guideline-recommended LDL-C target, reinforcing urgent need ...
Posted by Michael Wonder on 31 Jul 2025
EMA CHMP adopts positive opinion recommending authorisation of Moderna's COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant LP.8.1
25 July 2025 - Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European ...
Posted by Michael Wonder on 30 Jul 2025
Health Canada expands approval of Scemblix, making it an option for newly diagnosed and previously treated chronic myeloid leukaemia patients
30 July 2025 - Scemblix is first to show superior efficacy and a favourable safety and tolerability profile in a Phase ...
Posted by Michael Wonder on 30 Jul 2025
Johnson & Johnson files with US FDA to include new evidence in Tremfya (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis
29 July 2025 - Submission is supported by 24 week results from the Phase 3b APEX study in adults with active ...
Posted by Michael Wonder on 29 Jul 2025
AbbVie submits for US FDA approval of combination treatment of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukaemia
29 July 2025 - Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in ...
Posted by Michael Wonder on 29 Jul 2025
Tofersen approved by the MHRA to treat rare inherited form of motor neurone disease
28 July 2025 - New genetic therapy approved for SOD1-ALS brings targeted treatment option to patients in the UK. ...
Posted by Michael Wonder on 29 Jul 2025
BeOne Medicines receives positive CHMP opinion for Tevimbra in neo-adjuvant/adjuvant NSCLC treatment
28 July 2025 - Recommendation based on Phase 3 RATIONALE-315 study, in which Tevimbra demonstrated clinically meaningful and statistically significant improvement ...
Posted by Michael Wonder on 29 Jul 2025
Alteogen receives positive CHMP opinion for aflibercept biosimilar, 'Eyluxvi (ALT-L9)'
28 July 2025 - Upon approval, Eyluxvi will be Alteogen's second biosimilar product, following a Herceptin biosimilar by Alteogen's license ...
Posted by Michael Wonder on 29 Jul 2025
CHMP recommends EU approval of Henlius’ denosumab biosimilar HLX14
28 July 2025 - Shanghai Henlius Biotech announced today that the EMA's CHMP has adopted a positive opinion for HLX14, the ...