Harvard Medical School professor Jerry Avorn says recent court decisions banning compelled speech could be interpreted to stop FDA from requiring full...
Seven Gibson Dunn attorneys say the government is pursuing False Claims Act cases involving cybersecurity claims by device manufacturers.
BrainStorm Cell Therapeutics says it is withdrawing a BLA for its NurOwn ALS treatment technology and will work with FDA on a path forward for the tre...
Federal Register notice: FDA posts a list of six information collections that have been approved by OMB.
Federal Register notice: FDA determines that Fresenius Kabi USAs Naropin (ropivacaine HCl) solution was not withdrawn due to safety or effectiveness r...
FDA publishes an immediately effective guidance removing an expiration for some enforcement policies for certain non-invasive remote monitoring device...
FDA approves a UCB BLA for Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic thera...
FDA clears an Intellia Therapeutics IND to permit a Phase 3 trial of its NTLA-2001 to treat transthyretin amyloidosis with cardiomyopathy.
