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RSS FeedPosted by Michael Wonder on 26 Feb 2025
Opus Genetics announces FDA fast track and enrollment updates for phentolamine ophthalmic solution 0.75% programs
26 February 2025 - Enrollment completion in LYNX-2 pivotal Phase 3 trial expected in first half of 2025. ...
Posted by Michael Wonder on 26 Feb 2025
Odronextamab BLA accepted for FDA review for the treatment of relapsed/refractory follicular lymphoma
26 February 2025 - FDA decision expected by 30 July 2025. ...
Posted by Michael Wonder on 26 Feb 2025
EMA accepts marketing authorisation application for ND0612, an investigational treatment for motor fluctuations in Parkinson’s disease
21 February 2025 - Mitsubishi Tanabe Pharma today announced the EMA has accepted for review the marketing authorisation application for ...
Posted by Michael Wonder on 26 Feb 2025
Osimertinib mesylate for the adjuvant treatment of patients with EGFR mutation positive non-small-cell lung cancer after complete tumour resection (final guidance)
26 February 2025 - NICE has published final evidence-based recommendations on the use of osimertinib mesylate (Tagrisso) for the adjuvant ...
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 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 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 ...