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 31 Jul 2025
Glofitamab in combination with gemcitabine hydrochloride and oxaliplatin for the treatment of patients with relapsed or refractory diffuse large Bcell lymphoma
29 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
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
Agenda for the November 2025 PBAC meeting
30 July 2025 - The agenda for the November 2025 PBAC meeting is now available. ...
Posted by Michael Wonder on 30 Jul 2025
MSAC publishes agenda for November 2025 MSAC meeting
30 July 2025 - The MSAC Secretariat has published a list of applications scheduled to be considered by the MSAC ...
Posted by Michael Wonder on 30 Jul 2025
CDA issues positive reimbursement recommendation for Skyclarys (omaveloxolone), the only Health Canada approved treatment for managing Friedreich ataxia
29 July 2025 - Biogen Canada is pleased to announce a significant step forward for Canadians living with Friedreich ataxia, ...
Posted by Michael Wonder on 30 Jul 2025
Novartis and the pan-Canadian Pharmaceutical Alliance achieve milestone agreement on Cosentyx for hidradenitis suppurativa (
23 July 2025 - Following this important milestone, Cosentyx has been listed in Québec. ...
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 30 Jul 2025
Calidi Biotherapeutics receives FDA fast track designation for CLD-201 (SuperNova), a first in class stem cell loaded viral therapy for the treatment of patients with soft tissue sarcoma
29 July 2025 - Calidi Biotherapeutics today announced that it received fast track designation from the US FDA for CLD-201 (SuperNova), ...
Posted by Michael Wonder on 30 Jul 2025
Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of severe to very severe alopecia areata
29 July 2025 - Nektar Therapeutics today announced that the US FDA has granted fast track designation for rezpegaldesleukin for the ...
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 ...
Posted by Michael Wonder on 29 Jul 2025
Zevra Therapeutics submits marketing authorisation application to EMA to review arimoclomol for the treatment of Niemann-Pick disease type C
28 July 2025 - Zevra Therapeutics announced the company submitted a marketing authorisation application to the EMA for the evaluation of ...