In 2023, a record nine designations were awarded to mRNA vaccines for eight conditions, displaying the FDA’s commitment to encouraging the development of these products across a broader range of indications.
Following a series of acquisitions and recently-launched global partnerships, these promotions signal the next phase in the agency’s strategic growth plan, while also demonstrating its commitment to cultivating strong leadership from within.
Merck KGaA’s drug candidate xevinapant in a late-stage trial was unable to significantly improve event-free survival in patients with locally advanced head and neck cancer.
Yesterday Grail announced that it has successfully completed its spinoff from DNA sequencing giant Illumina, paving the way for its debut on the Nasdaq Global Select Market.
The company stated that FDA had declined to approve its therapy to treat motor fluctuations in Parkinson’s disease patients, citing manufacturing concerns at a third-party manufacturer.
The blockbuster cancer drug Imfinzi has failed as a follow-up therapy to improve disease-free survival in a late-stage trial in patients with a type of early-stage lung cancer.