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 24 Jun 2022
BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer
23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...
Posted by Michael Wonder on 24 Jun 2022
Astellas submits fezolinetant new drug application to U.S. FDA
24 June 2022 - Application targets treatment of moderate to severe vasomotor symptoms associated with menopause ...
Posted by Michael Wonder on 23 Jun 2022
Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process
23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...
Posted by Michael Wonder on 23 Jun 2022
FDA explains when it will rescind breakthrough designations
23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...
Posted by Michael Wonder on 23 Jun 2022
Calls to expand access to oral COVID-19 drugs as expiry dates loom
23 June 2022 - Thousands of doses of expensive anti-viral drugs could be wasted if more Australians do not become ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...
Posted by Michael Wonder on 23 Jun 2022
Industry sponsorship bias in cost effectiveness analysis: registry based analysis
22 June 2022 - The Tufts Cost-Effectiveness Analysis Registry was used to identify all CEAs published in Medline between 1976 and ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
Posted by Michael Wonder on 23 Jun 2022
Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab injection) by China NMPA in combination with chemotherapy as first-line treatment for oesophageal squamous cell carcinoma
20 June 2022 - Innovent Biologics and Eli Lilly today announced that the Center for Drug Evaluation of China's National ...
Posted by Michael Wonder on 23 Jun 2022
NICE opts to reject Acorda’s MS drug Fampyra
22 June 2022 - NICE has announced its decision to reject Fampyra – also known as fampridine – for use ...
Posted by Michael Wonder on 23 Jun 2022
COVID-19 vaccine weekly safety report (23 June 2022)
23 June 2022 - To 19 June 2022, the TGA has received 581 reports which have been assessed as likely to ...
Posted by Michael Wonder on 23 Jun 2022
Menarini Group and Radius Health submit new drug application to the U.S. FDA for elacestrant
22 June 2022 - Priority review requested; if accepted, anticipate an 8 month FDA review. ...
Posted by Michael Wonder on 23 Jun 2022
Novartis receives European Commission approval for Tabrecta for the treatment of METex14 skipping advanced non-small cell lung cancer
22 June 2022 - Approval based on the Phase II GEOMETRY mono-1 trial, which showed an overall response rate of 51.6% ...
Posted by Michael Wonder on 23 Jun 2022
Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C
22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...
Posted by Michael Wonder on 23 Jun 2022
Novartis Tafinlar and Mekinist receives FDA approval for first tumour agnostic indication for BRAF V600E solid tumours
22 June 2022 - Approval supported by results from Phase II ROAR and NCI-MATCH studies demonstrating overall response rates up to ...