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 26 Jan 2022
Catalyst Biosciences receives rare paediatric disease designation for CB 4332 for the treatment of CFI deficiency
25 January 2022 - Catalyst Biosciences today announced the U.S. FDA has granted rare paediatric disease designation for CB 4332 for ...
Posted by Michael Wonder on 26 Jan 2022
Incyte provides update on parsaclisib and MCLA-145
25 January 2022 - Incyte today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of ...
Posted by Michael Wonder on 25 Jan 2022
SNIPR BIOME announces US FDA grants fast track designation for SNIPR001 for prevention of bloodstream infections in haematologic cancer patients
25 January 2022 - SNIPR Biome has been granted fast track designation by the US FDA for SNIPR001. ...
Posted by Michael Wonder on 25 Jan 2022
Senhwa’s pidnarulex receives US FDA fast track designation for the treatment of solid tumours with BRCA1/2, PALB2 and other HR gene mutations
24 January 2022 - Senhwa Biosciences announced today that the US FDA has granted fast track designation for Pidnarulex, a first ...
Posted by Michael Wonder on 25 Jan 2022
Genentech’s Evrysdi (risdiplam) granted FDA priority review for treatment of presymptomatic babies under 2 months of age with spinal muscular atrophy
24 January 2022 - Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi for at least ...
Posted by Michael Wonder on 25 Jan 2022
ICER releases draft evidence report on novel agents to prevent chemotherapy-induced neutropenia
25 January 2022 - Registration now open for 1 February “Early Insights” webinar. Public comment period now open until 22 ...
Posted by Michael Wonder on 25 Jan 2022
Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched
25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment 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 ...