The new initiative is intended to improve the global oversight of medical devices, AI, and innovative medicines and to streamline knowledge sharing efforts.
The FDA granted the status to alixorexton for idiopathic hypersomnia while the EC approved the designation for narcolepsy.
The Phase III EPCORE DLBCL-1 met one of the two endpoints, with Genmab set to discuss next steps with global regulatory authorities.
AvenCell Therapeutics presented updated results for its CAR-T cell blood cancer therapy at EHA 2026.
The FDA has cleared several oncology products over the past few days, ranging from therapies to diagnostic and imaging tools.
The MHRA’s approval of a lower dose of EURneffy means more children will have a needle-free option to treat anaphylaxis.
