Increase in dry powder inhalers could lead to decreases in greenhouse gas emissions
As dry powder inhalers are breath controlled, no propellant is used, making their carbon footprint significantly lower than that of…
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FDA grants Orphan Drug status to Aro Biotherapeutics’ Pompe disease therapy
The company plans to advance ABX1100 into clinical trials in the middle of next year.
FDA grants Fast-Track status for Relmada’s major depressive disorder therapy
In a Phase II trial, REL-1017 was found to offer quick and long-lasting antidepressant effects.
Health Canada accepts Paladin’s NDS for epilepsy-linked seizure therapy
Discovered by SK Biopharmaceuticals and SK life science, cenobamate is a new small molecule anti-seizure therapy.
FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment
The BLA is based on positive data from various studies of N-803, including the Phase II/III QUILT 3.032 trial.
EMA task force begins review of Veru’s sabizabulin for Covid-19
The ETF will analyse all the available data, including findings from a trial in moderate-to-severe Covid-19 patients.
FDA grants priority review for Biogen’s tofersen to treat ALS
The NDA for tofersen comprised data from a Phase I trial, a Phase I/II trial, a Phase III VALOR trial…
FDA accepts BLA for Sandoz’s proposed biosimilar natalizumab
A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions.