There is no demonstrated benefit of Teva's Azilect (rasagiline) for slowing the rate of progression of Parkinson's disease, a US FDA drug reviewer said, insisting that the company's data were "not robust" enough to support such a claim.
There is no demonstrated benefit of Teva's Azilect (rasagiline) for slowing the rate of progression of Parkinson's disease, a US FDA drug reviewer said, insisting that the company's data were "not robust" enough to support such a claim.
While Dr Leonard Kapcala, a clinical reviewer in the FDA's Division of Neurology Products, said he was deferring his final...
Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.
Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.
Oral RNA splicing modulator has gone into a Phase II/III trial
Wales-based group launches with $140m series A.
Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.
Multi-blockbuster falls short in a giant cell arteritis study.
4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.
