Author: PharmaSignal News Desk

FDA foreign inspections increase, targeting drug manufacturers without notice, as Commissioner Makary outlines new strategy.

Novartis Tourmaline Bio acquisition for $1.4bn expands its cardiovascular portfolio with pacibekitug.

Merck ADC lung cancer treatment shows nearly 50% tumor shrinkage in mid-stage trial, heading to FDA.

Amneal FDA warning highlights use of contaminated bags in sterile injectable drugs, impacting quality control.

Roche CE mark Contivue advances Susvimo for nAMD in Europe, potentially benefiting 1.7 million people.

Gilead AI manufacturing hub breaks ground in US, creating over 3,000 jobs and boosting biopharma innovation.

OMass Genentech collaboration targets inflammatory bowel disease with a $400 million deal, leveraging OdyssION platform.

Biohaven Vyglxia FDA approval leads to launch preparations, with a patient hub and sales force ready.

FDA approves Leqembi Iqlik as a weekly subcutaneous injection for Alzheimer’s, enhancing patient convenience and safety.

Avadel licenses sleep drug for $20M upfront, expanding its portfolio with XWPharma’s valiloxybate.