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 20 Jul 2022
Karyopharm granted regulatory designations for eltanexor for the treatment of myelodysplastic syndromes
20 July 2022 - FDA fast track designation and European Commission orphan medicinal product designation underscore the significant need for ...
Posted by Michael Wonder on 20 Jul 2022
Easier access to locally applied HRT to treat post-menopausal vaginal symptoms in landmark MHRA reclassification
20 July 2022 - From September women in the UK will be able to access Gina 10 microgram vaginal tablets without ...
Posted by Michael Wonder on 20 Jul 2022
Statement by President Joe Biden on FDA and CDC authorising Novavax’s COVID-19 vaccine for adults
19 July 2022 - Today is another step forward in our nation’s fight against the virus. Following an independent scientific review ...
Posted by Michael Wonder on 20 Jul 2022
Pfizer and BioNTech complete submission to European Medicines Agency for Omicron BA.1 adapted bivalent vaccine candidate
19 July 2022 - Pfizer and BioNTech today announced they have completed a submission to the EMA for an Omicron-adapted bivalent ...
Posted by Michael Wonder on 19 Jul 2022
Wugen receives US FDA fast track and rare paediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL
19 July 2022 - Wugen, today announced that the U.S. FDA has granted fast track designation and rare paediatric disease ...
Posted by Michael Wonder on 19 Jul 2022
Ascentage Pharma and Innovent announce the China NMPA accepted and granted priority review designation to a new drug application for olverembatinib for the treatment of drug resistant CML
19 July 2022 - Ascentage Pharma and Innovent Biologics today announce that the Center for Drug Evaluation of China's NMPA ...
Posted by Michael Wonder on 19 Jul 2022
ICER publishes final evidence report and policy recommendations on beti-cel gene therapy for beta thalassaemia
19 July 2022 - Independent appraisal committee unanimously determined that evidence is adequate to demonstrate that beti-cel provides a net ...
Posted by Michael Wonder on 19 Jul 2022
German Government announces bill to drastically slash drug reimbursement
19 July 2022 - On 8 July 2022, the German Health Ministry has officially shared the second edition of a new ...
Posted by Michael Wonder on 19 Jul 2022
Peptilogics receives FDA fast track designation for PLG0206, an investigational peptide therapeutic in development for the treatment of peri-prosthetic joint infection
19 July 2022 - PLG0206 has the potential to be the first approved therapy specifically indicated for the treatment of peri-prosthetic ...
Posted by Michael Wonder on 19 Jul 2022
NeuroStar advanced therapy for mental health receives FDA clearance for treatment of anxious depression
19 July 2022 - Indication demonstrates NeuroStar TMS safety and efficacy in improving anxiety symptoms in depressed patients. ...
Posted by Michael Wonder on 19 Jul 2022
Apellis announces FDA acceptance and priority review of the new drug application for pegcetacoplan for the treatment of geographic atrophy
19 July 2022 - PDUFA target action date is 26 November 2022. ...
Posted by Michael Wonder on 19 Jul 2022
Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease
19 July 2022 - The Elecsys Amyloid Plasma Panel is intended to be used in conjunction with other clinical information in ...
Posted by Michael Wonder on 19 Jul 2022
Daewoong's idiopathic pulmonary fibrosis drug gets FDA's fast track status
19 July 2022 - Daewoong Pharmaceutical said that the US FDA had granted fast track designation to its idiopathic pulmonary ...
Posted by Michael Wonder on 19 Jul 2022
Incyte announces U.S. FDA approval of Opzelura (ruxolitinib) cream for the treatment of vitiligo
18 July 2022 - Phase 3 data supporting the approval show treatment with Opzelura resulted in improvements in facial and total ...
Posted by Michael Wonder on 19 Jul 2022
Genmab announces that AbbVie will submit marketing authorisation application to EMA for epcoritamab for the treatment of relapsed/refractory diffuse large B-cell lymphoma
18 July 2022 - Genmab today announced that AbbVie will submit a conditional marketing authorisation application with the EMA for ...