Definium Therapeutics plans to submit an NDA for LSD-based psychedelic, DT120 in generalised anxiety disorder (GAD) during H1 2027.
Cell and gene therapies are fuelling new possibilities for rare diseases, turning a field defined by unmet need into one of the industry’s most dynamic areas of innovation.
The FDA's latest efforts to curb the illicit US medicines trade are primarily centred around weight loss and fat-reducing peptides.
The HHS appoints these leadership positions as it looks to “reform” the FDA, which has recently faced a high turnover in leadership.
A survey of 175 pharma executives highlights an increasing reluctance to launch in lower-value markets, alongside a heightened focus on RWE.
Encoded Therapeutics has raised $275m in a Series F financing round to advance development of its disease-modifying therapy (DMT) for Dravet syndrome, with an eye also on initiati ...
ABEC is to open a new manufacturing facility in Wilson, North Carolina, US, expanding its network for biopharmaceutical process equipment.
Though yet to be finalised, the initial recommendation would mean the injectable PrEP would not be covered on the NHS.
At ERS 2026, investigators reported their findings from their review of the Oxford Asthma Attack Risk Scale Meta-Analysis (ORACLE2).
Novartis has signed an agreement with Alteogen that could be worth up to $3.22bn for the development and commercialisation of subcutaneous drug formulations using Alteogen’s ALT-B4 technology.
As regulatory enforcement surges, life science manufacturers must shift away from paper-based systems to ensure compliance.
Ionis claims Zanvastro will become available to US patients with rare neurodegenerative condition, Alexander disease “in the coming weeks”.
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