Editor-in-chief Jonah Comstock lays out a few of the most potent threads he heard in the conference centres, hotel rooms, and rain-soaked Lyfts of San Francisco.
The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talqueta
The FDA's interactions with Biogen in the build-up to last year's controversial approval of Alzheimer's disease therapy Aduhelm have been described as "inappropriate" and "atypical" in a co
After years of preparation, the US Congress passed the Pre-approval Information Exchange (PIE) Act just ahead of the Christmas break, legislation that will allow medical payers and the FDA
The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023.
