All articles by Manish Kumar
Manish Kumar
Elixirgen Therapeutics granted FDA RMAT designation for EXG-34217
Enrollment is currently open for participants aged 12 and older, regardless of gender or ethnicity
FDA removes dosing limitation for Astellas’ Izervay in geographic atrophy treatment
The FDA’s decision allows Izervay to be administered without a dosing duration restriction, providing greater flexibility for physicians and patients in managing geographic atrophy
FDA approves Pfizer’s Adcetris combo for relapsed b-cell lymphoma
The approval is based on positive Phase 3 ECHELON-3 results in which the Adcetris regimen showed improved overall survival and reduced risk of death
NKGen Biotech receives US FDA Fast Track Designation for Troculeucel
The Fast Track designation accelerates troculeucel’s path to U.S. FDA submission for the treatment of patients with moderate Alzheimer’s disease
Merck’s Keytruda approved for Stage II-III NSCLC in Canada
The approval is based on positive Phase 3 KEYNOTE-671 trial results, showing improved event-free survival and overall survival versus placebo treatments
Oramed to spin off oral insulin technology into OraTech joint venture
The spin-off aims to speed up the development and commercialisation of Oramed’s ORMD-0801 oral insulin and other oral drug delivery innovations
Biohaven announces FDA acceptance and priority review of Troriluzole
Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment
Merck in talks to acquire US cancer and rare disease firm SpringWorks
SpringWorks is developing treatments for rare tumours and uterine cancer, with FDA-approved Ogsiveo and upcoming approval for mirdametinib to treat neurofibromatosis type-1
Pfizer reports positive long-term results for Padcev, Keytruda combo in urothelial cancer
The latest results show sustained OS and PFS benefits after 29.1 months, consistent with earlier findings from the primary analysis following 12 additional months of follow-up
Bayer files for approval of extended 6-month treatment interval for Eylea 8mg in the EU
Submission is based on positive three-year results from the open-label extension studies of the clinical trials PULSAR (in nAMD) and PHOTON (in DME)