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 29 Jun 2022
NICE publishes its 800th technology assessment
29 June 2022 - TAs 799 and 800 are for the same technology. ...
Posted by Michael Wonder on 29 Jun 2022
Eylea (aflibercept) injection sBLA for every 16 week dosing regimen in patients with diabetic retinopathy accepted for FDA review
29 June 2022 - If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved ...
Posted by Michael Wonder on 29 Jun 2022
Ipsen announces U.S. FDA priority review for palovarotene new drug application in patients with fibrodysplasia ossificans progressiva following resubmission
29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...
Posted by Michael Wonder on 28 Jun 2022
Health Canada approves Opdivo (nivolumab) as monotherapy for the adjuvant treatment of adults with urothelial carcinoma at high risk of recurrence after undergoing radical resection of urothelial carcinoma
28 June 2022 - First adjuvant Immunotherapy for patients at high risk of disease recurrence. ...
Posted by Michael Wonder on 28 Jun 2022
The Innovative Medicines Fund - good news for patients but has an opportunity been missed to be more ambitious?
27 June 2022 - NHS England and Improvement has announced the launch of the Innovative Medicines Fund. The ABPI’s Director ...
Posted by Michael Wonder on 28 Jun 2022
Monkeypox: EMA starts review for Imvanex
28 June 2022 - The EMA’s CHMP has started a review of data to extend the use of the smallpox ...
Posted by Michael Wonder on 28 Jun 2022
Apnimed granted FDA fast track designation for AD109, a novel first in class oral pharmacologic combination for the treatment of obstructive sleep apnoea
28 June 2022 - Additional Phase 2b data evaluating AD109 as potential treatment for obstructive sleep apnoea anticipated in Q3 ...
Posted by Michael Wonder on 28 Jun 2022
Janssen receives positive CHMP opinion for Imbruvica (ibrutinib) in a fixed-duration combination regimen for adult patients with previously untreated chronic lymphocytic leukaemia
24 June 2022 - The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated ...
Posted by Michael Wonder on 28 Jun 2022
Kyowa Kirin receives positive CHMP opinion for use of Crysvita (burosumab) for the treatment of tumour-induced osteomalacia
24 June 2022 - Crysvita could offer access to the first biologic treatment for EU patients with tumour-induced osteomalacia who cannot ...
Posted by Michael Wonder on 28 Jun 2022
Gilead resubmits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor
27 June 2022 - NDA Resubmission Addresses Issues Related to Vial Compatibility. ...
Posted by Michael Wonder on 28 Jun 2022
Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab) by China NMPA in combination with chemotherapy as first-line treatment of advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma
26 June 2022 - Innovent Biologics and Eli Lilly announced that the NMPA of China has approved the supplemental new drug ...
Posted by Michael Wonder on 28 Jun 2022
Nexviadyme (avalglucosidase alfa) approved by European Commission as a potential new standard of care for the treatment of Pompe disease
28 June 2022 - Approved for the treatment of the full spectrum of both late-onset Pompe disease and infantile-onset Pompe disease. ...
Posted by Michael Wonder on 28 Jun 2022
Cosentyx (secukinumab) receives expanded approvals in EU for use in childhood arthritic conditions
27 June 2022 - Approvals based on data from the JUNIPERA trial, showing that Cosentyx® (secukinumab) reduced the risk of flare ...
Posted by Michael Wonder on 28 Jun 2022
Xenpozyme (olipudase alfa) approved by European Commission as first and only treatment for ASMD
28 June 2022 - The European Commission has approved Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy for ...
Posted by Michael Wonder on 28 Jun 2022
Fees and charges: summary from 1 July 2022
27 June 2022 - The TGA has updated its summary of fees and charges effective 1 July 2022. ...