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 Apr 2022
ObsEva announces confirmation of positive CHMP opinion for linzagolix, an oral GnRH antagonist, for the treatment of uterine fibroids
25 April 2022 - ObsEva today announced that the CHMP of the EMA has confirmed its previously adopted positive opinion, ...
Posted by Michael Wonder on 25 Apr 2022
Is it best to remove insurance benefits from drugs prescribed in bribery?
25 April 2022 - The Ministry of Health and Welfare’s Health Insurance Policy Review Committee is scheduled to hold a ...
Posted by Michael Wonder on 25 Apr 2022
FDA approves first COVID-19 treatment for young children
25 April 2022 - Today, the US FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include paediatric ...
Posted by Michael Wonder on 25 Apr 2022
FDA grants regenerative medicine advanced therapy designation to Autolus’ CAR T cell therapy, obe-cel, for the treatment of adult B-ALL
25 April 2022 - Autolus Therapeutics today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation to its ...
Posted by Michael Wonder on 25 Apr 2022
Sol-Gel Technologies and Galderma Announce FDA approval of Epsolay
25 April 2022 - Epsolay (5% benzoyl peroxide topical cream) utilises Sol-Gel’s proprietary microencapsulation technology for the treatment of inflammatory lesions ...
Posted by Michael Wonder on 25 Apr 2022
Tremelimumab accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi
25 April 2022 - STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual ...
Posted by Michael Wonder on 25 Apr 2022
Swissmedic grants conditional marketing authorisation for Novavax COVID-19 vaccine
13 April 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine authorised for use in Switzerland. ...
Posted by Michael Wonder on 24 Apr 2022
Update on regulatory submission for aducanumab in the European Union
22 April 2022 - Biogen has notified the EMA of its decision to withdraw its marketing authorisation application for aducanumab for ...
Posted by Michael Wonder on 24 Apr 2022
CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment for a subset of people with early-stage non-small-cell lung cancer
22 April 2022 - In the Phase III IMpower010 trial, adjuvant Tecentriq reduced the risk of disease recurrence or death by ...
Posted by Michael Wonder on 24 Apr 2022
CHMP adopts positive opinion for Filsuvez for the treatment of dystrophic and junctional EB
22 April 2022 - Positive opinion based on largest ever pivotal global Phase 3 EASE trial undertaken in epidermolysis bullosa. ...
Posted by Michael Wonder on 24 Apr 2022
Novartis receives positive CHMP opinion for Tabrecta for patients with METex14 advanced non-small-cell lung cancer
22 April 2022 - Opinion based on Phase 2 GEOMETRY mono-1 study showing an overall response rate (ORR) of 51.6% ...
Posted by Michael Wonder on 23 Apr 2022
CHMP recommends EU conditional approval of Roche’s potential first in class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma
22 April 2022 - The recommendation is based on the GO29781 study where mosunetuzumab induced high complete response rates, with ...
Posted by Michael Wonder on 23 Apr 2022
Highlights from the 19-22 April 2022 CHMP meeting
22 April 2022 - The EMA’s CHMP recommended four medicines for approval in the European Union at its April 2022 ...
Posted by Michael Wonder on 23 Apr 2022
Canada is settling for half measures on drug price regulations
22 April 2022 - After a two-year delay, new federal regulations for patented medicine prices will come into force this ...
Posted by Michael Wonder on 23 Apr 2022
Medexus Pharmaceuticals announces resubmission of treosulfan NDA
22 April 2022 - Additional data collection and analysis reconfirms confidence in new drug application for treosulfan. ...