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 Feb 2025
GRIN Therapeutics receives FDA breakthrough therapy designation for radiprodil
25 February 2025 - Company preparing to initiate Phase 3 pivotal trial. ...
Posted by Michael Wonder on 25 Feb 2025
FDA grants priority review to Precigen's BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis with PDUFA target action date set for 27 August 2025
25 February 2025 - If approved, PRGN-2012 would be the first and only available FDA approved therapy for eligible patients ...
Posted by Michael Wonder on 25 Feb 2025
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus standard of care as peri-operative treatment for resectable locally advanced head and neck squamous cell carcinoma
25 February 2025 - Acceptance based on results from the KEYNOTE-689 trial: the first Phase 3 trial to demonstrate significant improvement ...
Posted by Michael Wonder on 25 Feb 2025
Glaukos announces FDA acceptance of NDA submission for Epioxa
24 February 2025 - PDUFA date set for 20 October 2025. ...
Posted by Michael Wonder on 25 Feb 2025
EMA validates Gilead’s marketing authorisation application and EU-Medicines for all application for twice yearly lenacapavir for HIV prevention
24 February 2025 - One application seeks European Commission authorisation; other application would facilitate availability in low and lower middle income ...
Posted by Michael Wonder on 24 Feb 2025
US FDA grants fast track designation to Coherent Biopharma’s CBP-1019
21 February 2025 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1019 for the treatment ...
Posted by Michael Wonder on 24 Feb 2025
Auron Therapeutics announces AUTX-703 granted fast track designation by the FDA for relapsed or refractory acute myelogenous leukaemia
24 February 2025 - Auron Therapeutics today announced that the US FDA has granted fast track designation to AUTX-703 for ...
Posted by Michael Wonder on 24 Feb 2025
US FDA accepts BMS’s supplemental biologics license application for Opdivo plus Yervoy for patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
24 February 2025 - Application based on analyses from the Phase 3 CheckMate-8HW clinical trial, in which Opdivo plus Yervoy demonstrated ...
Posted by Michael Wonder on 24 Feb 2025
The EMA has approved an additional subcutaneous administration option for Takhzyro (lanadelumab) for patients aged 12 years and above with recurrent attacks of hereditary angioedema
24 February 2025 - Takhzyro solution for injection in 2 mL pre-filled pen is now approved to facilitate subcutaneous administration in ...
Posted by Michael Wonder on 24 Feb 2025
EMA publishes agenda for 24-27 February 2025 CHMP meeting
24 February 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 23 Feb 2025
HIRA to remove 17 medicines from group 2 anti-cancer list, update reimbursement criteria
21 February 2025 - Korea's HIRA said it has decided to remove 17 medicines from the list of group 2 ...
Posted by Michael Wonder on 23 Feb 2025
Luxa Biotechnology announces FDA regenerative medicine advanced therapy designation granted to RPESC-RPE-4W transplantation for the treatment of dry age-related macular degeneration
19 February 2025 - Luxa Biotechnology today announced that the US FDA has granted regenerative medicine advanced therapy designation to RPESC-RPE-4W ...
Posted by Michael Wonder on 22 Feb 2025
Health Canada authorizes Itovebi (inavolisib film-coated tablets), a targeted treatment for advanced hormone receptor-positive, HER2 negative breast cancer with a PIK3CA mutation
19 February 2025 - The approval provides another treatment option for breast cancer patients with a PIK3CA mutation, one of the ...
Posted by Michael Wonder on 21 Feb 2025
Alvotech and Teva announce filing acceptance of US biologics license application for AVT06, a proposed biosimilar to Eylea (aflibercept)
18 February 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review a biologics license ...
Posted by Michael Wonder on 21 Feb 2025
Green light for groundbreaking personalised cancer therapy that reprogrammes immune system
20 February 2025 - Final guidance published today recommends lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb) as an option for treating ...