FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) and its use in combination with AVD chemotherapy for ad...
The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face liability for induc...
Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time to first agency post...
The Washington Legal Foundation cautions that the Trump administrations ongoing crackdown on direct-to-consumer pharmaceutical advertising is on a col...
FDA approves Italian non-profit Fondazione Telethons BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome.
Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not comply with BLA requ...
FDA warns Brookhaven, GA-based Ponya Therapeutics about violations of regulations governing human cells, tissues, and cellular and tissue-based produc...
FDA clears a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults with attention-deficit/hyper...
