A digital twin commissioned to mirror a manufacturing process is, by design, built to keep learning. It ingests live sensor data, recalibrates its internal parameters, and narrows the gap between what it predicts and what the physical process is actually doing. That's...
I like to call myself a conduit between ancient healing wisdom and modern life. I came to the US thirty years ago to be trained as a pathologist, but I grew up among generations of herbalists. My family roots and my research background have shaped how I view the...
For most of the past three decades, validating a computerised system in a GMP facility has usually meant paper. Teams compiled binders of test scripts, wet-ink signatures and printed screenshots. That model is now under pressure, and digital validation in life...
The resignation of Anthropic researcher Jacob Coxon has brought renewed attention to the risks of increasingly powerful artificial intelligence. According to the Associated Press, Coxon warned that competitive pressure was overtaking safety considerations at leading...
Cosmetics regulation rarely makes it onto the radar of pharma, biotech, or medical device professionals. It probably should, at least for the next few years. The European Union is in the middle of building two overlapping restriction regimes, one for PFAS and one for...
Daiichi Sankyo and Merck withdrew a US small cell lung cancer treatment filing for ifinatamab deruxtecan. LSDN examines the UK access gap.
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...
The US Food and Drug Administration cleared two zanidatamab regimens on 25 August 2026. The zanidatamab approval covers first-line treatment of HER2-positive advanced gastro-oesophageal adenocarcinoma. It displaces trastuzumab from a first-line backbone that has...
The Genglycos gene therapy approval gives patients with glycogen storage disease type Ia a new option. The FDA describes it as the first approved treatment for the condition. It is designed to address the underlying cause. The US Food and Drug Administration granted...
Capital is flowing to the wrong point on the disease timeline Kidney care has attracted more than $2.5 billion in investment capital over the past five years. The amount tells a clear story. Unfortunately, it may be the wrong one. Investment has mostly concentrated on...
Misaligned incentives, the wrong unit of work, and a probabilistic model where the process demands a reproducible one A draft annex to European GMP guidance, out for consultation until October 2025, contains the bluntest sentence yet written about AI in regulated...
New approach methodologies have moved from the margins of preclinical science to the centre of regulatory policy. Since publishing its Roadmap to Reducing Animal Testing in Preclinical Safety Studies in April 2025, the United States Food and Drug Administration has...
The European Union has rewritten its sustainability disclosure rules. The consequences for the life sciences sector are substantial. CSRD reporting was once expected to capture tens of thousands of companies across the bloc. It now applies to a far smaller group of...
The United States Food and Drug Administration has selected seven pharmaceutical and biotechnology companies for its FDA PreCheck Program, a pilot initiative designed to accelerate the establishment of new domestic drug manufacturing facilities. Announced on 7 August...
Retatrutide, Eli Lilly’s investigational triple hormone receptor agonist, has now reported positive results across five Phase 3 trials. In the pivotal TRIUMPH-1 obesity study, participants on the highest dose lost an average of 28.3% of their body weight at 80 weeks,...
Last updated 28 October 2026. Covering target action dates from October 2026 to February 2027. October changed how this tracker has to be read. Six FDA drug approval decisions landed in the month, and four arrived ahead of target. One cleared roughly 12 weeks early,...
As the FDA considers reclassifying seven popular peptides, experts say the decision could change how patients access these compounds. As the FDA evaluates whether several commonly used peptides should become eligible for pharmacy compounding, the outcome could...
A pharmaceutical manufacturer completes a technology transfer. The validation protocols have been approved. Training records are complete, documentation has been reviewed, and every required signature has been collected. The project passes its milestones and moves...