The FDA is planning to take an additional three months to review Biogen's experimental therapy for amyotrophic lateral sclerosis (ALS), setting back its decision date from January to April.
AstraZeneca has taken the decision not to move a PCSK9-targeting antisense drug licensed from Ionis into a phase 3 programme, removing a competitor to Novartis' rival therapy Leqvio.
The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short
Patients with end-stage renal disease (ESRD) who are on dialysis often need to be treated with anticoagulants to prevent blood clots, but as a result, can experience bleeding side effects.
Armed with new phase 3 data, AstraZeneca is preparing to file for regulatory approval of eplontersen, an antisense drug for one of the complications of the disease transthyretin amyloidosis
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