Kivo reports a rise in FDA warning letters to drug firms due to documentation failures, with 94% citing recordkeeping issues.

Inconsistent reporting at a Pennsylvania site affected microbiological analyses of components and drug products that ...

This article explores the recent trends in India's compliance with the US FDA, highlighting improvements in inspection ...

Haemonetics stock edges higher on the day, trading at $118.73 while the PerQseal Elite system receives FDA approval.

Quick Fix Synthetic, the official distributor of Spectrum Labs' Quick Fix products, today corrected one of the most-repeated numbers in drug testing, using new data Quest Diagnostics quietly published ...

Fractyl Health, Inc. stocks have been trading down by -68.51 percent amid heightened focus on its metabolic gene therapy ...

J&J's icotrokinra hit every UC endpoint in NEJM's Oct 2026 data, and the trial design choices behind that success are ...

AI can generate 100x more drug candidates, but trials still need real patients. The bottleneck has shifted, and most sponsors ...

The new fiscal year is already two days into its own ledger. On 2 October 2026, FDA issued a letter to Hanlim Pharm in Yongin ...

The company said the three data sets together give a clearer picture of the product it actually sells than any single ...

In AD, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a ...

ZILBRYSQ is the first and only macrocyclic peptide C5 inhibitor approved as a self-administered once-daily, subcutaneous ...