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 25 Jan 2022
Oncopeptides withdraws withdrawal of first marketed drug
24 January 2022 - Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S FDA and rescinded its 22 ...
Posted by Michael Wonder on 25 Jan 2022
Bimzelx (bimekizumab) approved in Japan for the Treatment of plaque psoriasis, generalised pustular psoriasis and psoriatic erythroderma
24 January 2022 - The third approval for bimekizumab worldwide reinforces UCB’s commitment to bring new treatment options to the global ...
Posted by Michael Wonder on 25 Jan 2022
Vyepti (eptinezumab) approved by the EU Commission for the preventive treatment of migraine in adults
24 January 2022 - Vyepti is the first intravenous treatment approved for migraine prevention in Europe. ...
Posted by Michael Wonder on 25 Jan 2022
Magnesium Development Company announces FDA breakthrough device designation for resorbable HC screw
24 January 2022 - Magnesium Development Company's fixation solution, the HC Screw, has received the FDA’s breakthrough device designation, having exceeded ...
Posted by Michael Wonder on 25 Jan 2022
Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the Omicron variant
24 January 2022 - In light of the most recent information and data available, today, the FDA revised the authorizations ...
Posted by Michael Wonder on 24 Jan 2022
FDA approves Nucala (mepolizumab) 40 mg pre-filled syringe for children with severe eosinophilic asthma
24 January 2022 - This approval allows for at home administration in patients 6-11 years old with severe eosinophilic asthma. ...
Posted by Michael Wonder on 24 Jan 2022
Breast cancer patients in Scotland are set to receive tumour blasting wonder drug that starts working in weeks - sparking hopes of a wider rollout for NHS patients across the rest of the UK
23 January 2022 - A breast cancer drug that can melt away tumours in weeks has been given the green ...
Posted by Michael Wonder on 24 Jan 2022
Method paper: new version 6.1 comes into force
24 January 2022 - The innovations concern, among other things, the procedure for evidence searches for medical guidelines. New concept ...
Posted by Michael Wonder on 24 Jan 2022
Cook Medical receives FDA breakthrough designation for new drug eluting stent
21 January 2022 - Cook Medical has received breakthrough device designation from the US FDA on a new drug eluting stent ...
Posted by Michael Wonder on 24 Jan 2022
Codexis announces FDA orphan drug and rare paediatric disease designations for CDX-6512 for the treatment of homocystinuria
24 January 2022 - Codexis today announced that the U.S. FDA has granted the company orphan drug designation for CDX-6512 for ...
Posted by Michael Wonder on 24 Jan 2022
Health Canada approves Ipsen’s Sohonos (palovarotene) as the first approved treatment for fibrodysplasia ossificans progressiva
24 January 2022 - Ipsen today announced the Health Canada approval of Sohonos (palovarotene), an oral selective retinoic-acid receptor gamma agonist ...
Posted by Michael Wonder on 24 Jan 2022
Merck provides US and Japan regulatory update for gefapixant
24 January 2022 - Merck today announced that the US FDA has issued a complete response letter regarding Merck’s new drug ...
Posted by Michael Wonder on 24 Jan 2022
People with chronic myeloid leukaemia granted early access to Novartis’ investigational treatment
24 January 2022 - The Medicine and Healthcare products Regulatory Agency grants positive scientific opinion on use of asciminib as 3rd-line ...
Posted by Michael Wonder on 24 Jan 2022
EMA publishes agenda for 24-27 Jan CHMP meeting
23 January 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 24 Jan 2022
Chugai’s Actemra approved for additional indication of SARS-CoV-2 pneumonia in Japan
21 January 2022 - The approval is based on the results of several clinical studies in hospitalised patients with COVID-19. ...