Early research offers insight, but major gaps remain in understanding long term respiratory effects The rapid rise of CBD vaping products has outpaced the science and regulatory frameworks needed to fully understand their health implications. While early research...
The first Alexander disease treatment is approved in the US. LSDN on the trial data, the Recordati licence and the outlook for UK access.
uniQure filed the Huntington gene therapy submission with the FDA and MHRA on 2 September 2026. Inside the three-year data and the regulatory reset.
The avacopan UK suspension took effect on 1 September 2026. The MHRA stopped supply to new patients and set 1 March 2027 for revoking the UK marketing authorisation, after concluding the pivotal ADVOCATE study can no longer demonstrate efficacy.
The brepocitinib dermatomyositis approval landed on 27 August 2026. It is the first shift in a treatment field that has barely moved in decades. The US Food and Drug Administration cleared LISRAYA, an oral dual TYK2 and JAK1 inhibitor, for adults with dermatomyositis....
The daraxonrasib FDA approval, granted on 26 August 2026, gives metastatic pancreatic cancer its first approved targeted therapy. Revolution Medicines will sell the drug as Rasonque. The agency cleared it roughly six and a half months ahead of its goal date. For an...
Biotech companies today face a delicate balancing act: communicating innovation early enough to build credibility and momentum, while avoiding regulatory and commercial risks that can undermine long-term value. This tension is most evident in how companies talk about...
A German court has granted Halozyme a preliminary injunction that halts the sale of the subcutaneous version of Keytruda in Germany, marking a significant legal win in the companies’ high stakes patent dispute. The decision could complicate Merck’s plans for the...
China’s life sciences sector is poised for a potential regulatory shake-up this week, as stakeholders await clarity on data exclusivity and intellectual property (IP) protection reforms. Earlier this year, the National Medical Products Administration (NMPA) released a...
For decades, the laboratory rat has been the quintessential symbol of biomedical research. Yet, as 2025 draws to a close, a profound shift is reshaping the life sciences landscape. Global regulatory bodies are no longer merely encouraging alternatives to animal...
A Coordinated Effort to Accelerate Approvals The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have launched a new initiative inviting early adopters to trial an accelerated and aligned...
A panel of independent experts convened by the U.S. Food and Drug Administration (FDA) has recommended against approving GSK’s (GSK.L) blood cancer treatment Blenrep, citing concerns over known ocular side effects. The decision prompted a nearly 5% drop in the British...