Blog
RSS FeedPosted by Michael Wonder on 03 Mar 2025
Imfinzi-based perioperative regimen recommended for approval in the EU by CHMP for resectable non-small cell lung cancer
3 March 2025 - Recommendation based on AEGEAN Phase 3 trial results which showed Imfinzi reduced the risk of recurrence, ...
Posted by Michael Wonder on 02 Mar 2025
Authorisations of human medicinal products with a new active substance and additional indications 2024
28 February 2025 - 46 human medicinal products with new active substances authorised. ...
Posted by Michael Wonder on 02 Mar 2025
Highlights from the 24-27 February 2025 CHMP meeting
28 February 2025 - Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications. ...
Posted by Michael Wonder on 02 Mar 2025
Krystal Biotech receives positive CHMP opinion for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
28 February 2025 - EC approval decision anticipated in second quarter of 2025. ...
Posted by Michael Wonder on 27 Feb 2025
Swissmedic approves CSL Behring’s Andembry (garadacimab) for the prevention of recurrent attacks of hereditary angioedema
26 February 2025 - The approval marks the fifth regulatory approval of Andembry, reinforcing CSL’s decades long commitment to delivering ...
Posted by Michael Wonder on 27 Feb 2025
Kashiv BioSciences obtains marketing authorisation for pegfilgrastim injection from Health Canada
25 February 2025 - Kashiv BioSciences today announced that Health Canada has granted marketing authorisation for its pegfilgrastim injection, enabling its ...
Posted by Michael Wonder on 18 Feb 2025
Novartis’ Kisqali granted MHRA approval to treat early breast cancer patients
5 February 2025 - The medicine is already approved in the UK to treat advanced cases of the disease. ...
Posted by Michael Wonder on 18 Feb 2025
Nemolizumab approved to treat prurigo nodularis and atopic dermatitis for patients in the UK
17 February 2025 - This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure. ...
Posted by Michael Wonder on 08 Feb 2025
Bio-Thera Solutions announces regulatory filing acceptance for BAT2506, a proposed biosimilar to Simponi, in the European Union
7 February 2025 - The BAT2506 marketing authorisation application is based on a robust analytical, non-clinical and clinical data package comparing ...
Posted by Michael Wonder on 06 Feb 2025
Supernus announces FDA approval of Onapgo (apomorphine hydrochloride) for Parkinson’s disease
4 February 2025 - Supernus Pharmaceuticals announced today that the US FDA approved Onapgo (apomorphine hydrochloride) injection, formerly known as SPN-830, ...
Posted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 05 Feb 2025
Astellas submits new drug application for conditional approval of avacincaptad pegol for geographic atrophy in Japan
5 February 2025 - Ministry of Health, Labour and Welfare to evaluate avacincaptad pegol as potential first and only treatment for ...
Posted by Michael Wonder on 03 Jan 2025
GSK’s Nucala (mepolizumab) approved in China for treatment of adults with chronic rhinosinusitis with nasal polyps
3 January 2025 - This is the third indication for mepolizumab in China for an IL-5 mediated condition. ...
Posted by Michael Wonder on 03 Jan 2025
Innovent announces second new drug pplication of Dovbleron (taletrectinib adipate capsule, ROS1 inhibitor) was approved by China's National Medical Products Administration
2 January 2025 - Innovent Biologics today announced that China's National Medical Products Administration has approved the second new drug application ...
Posted by Michael Wonder on 11 Dec 2024
Delgocitinib approved to treat adult patients with moderate to severe chronic hand eczema
10 December 2024 - The MHRA has approved the medicine delgocitinib (Anzupgo) to treat moderate to severe chronic hand eczema in ...