In briefing notes released ahead of a key meeting on Tuesday, scientists at the US Food and Drug Administration describe uncertainty in the risks associated wit 30 October 2023
Privately-held gene editing company Verve Therapeutics has been cleared by the US regulator to go ahead with what will be the first in-human base editing study 26 October 2023
Independent data monitors have recommended that French microbiome specialist MaaT Pharma continue its Phase III ARES study without modification. 26 October 2023
The US business of South Korea's Celltrion Healthcare has secured approval for Zymfentra (infliximab-dyyb), a biosimilar of Johnson & Johnson’s Remicade. 24 October 2023
After scientific advisors recommended that the US regulator not approve a new amyotrophic lateral sclerosis (ALS) therapy, developer BrainStorm Cell Therapeutic 19 October 2023
UCB has won two approvals from the US Food and Drug Administration, one for a new first-in-class rare disease med and another, for Bimzelx (bimekizumab-bkzx), b 18 October 2023
A firm in Massachusetts, USA, has won approval for a new kind of medicine, a phosphate absorption blocker, which will be used to treat certain people with chron 18 October 2023
A formal disclosure from Aldeyra Therapeutics, suggesting a potential rejection from the US Food and Drug Administration, has stripped around 70% from the firm’ 17 October 2023
Britain’s largest drugmaker, AstraZeneca (LSE: AZN), has been granted a Priority Review for its bid to broaden the label for Tagrisso (osimertinib) in the USA. 16 October 2023
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.