A surgical robot system developed by Noah Medical and newly cleared by the FDA is out of this world—or, at least, the current world of …
Over the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that …
Dive Brief: The Food and Drug Administration has determined that the risk of a rare, but serious, clotting syndrome tied to Johnson & Johnson’s COVID-19 …
Dive Brief: Novartis is reevaluating its commitment to an experimental COVID-19 treatment originally developed by fellow Swiss drug company Molecular Partners after the Food and …
The Food and Drug Administration appears ready to raise its approval standards for a well-known class of cancer drugs due to concerns they aren’t helping …
Dive Brief: The Food and Drug Administration has cleared Gilead to restart some trials testing an experimental cancer drug the company acquired in a roughly …
A group of advisers to the Food and Drug Administration agreed Wednesday that COVID-19 vaccines will likely need to be updated to keep pace with …
Dive Brief: Akebia Therapeutics will lay off 42% of its workforce after the Food and Drug Administration last month rejected its most advanced experimental drug, …
Dive Brief: The Food and Drug Administration rejected an Akebia Therapeutics’ anemia pill vadadustat, the company announced Wednesday, over concerns the drug isn’t as safe as currently …
By a slim margin, advisers to the Food and Drug Administration have concluded that the agency should hold off approving a closely watched, experimental medicine …
The drug’s beginnings, according to the two former students there to see them, were quite humble. About a decade ago, Justin Klee and Josh Cohen …
Dive Brief: Vertex will begin late-stage testing of one of its top drug prospects later this month, announcing on Tuesday plans for a Phase 2/3 …
Dive Brief: The Food and Drug Administration has rejected an experimental cancer immunotherapy Eli Lilly and partner Innovent Biologics have been developing for a common …
Dive Brief: After receiving a rejection last year, Acadia said Wednesday that the Food and Drug Administration agreed to review its resubmitted application to expand …
Dive Brief: Karyopharm Therapeutics will have to perform a new clinical trial to widen the use of its cancer drug selinexor after U.S. regulators said …
The U.S. Senate on Tuesday voted to confirm Robert Califf as commissioner of the Food and Drug Administration, filling a position that had remained vacant …
Dive Brief: The Food and Drug Administration will decide whether to approve Bristol Myers Squibb’s cancer cell therapy Breyanzi for earlier use by late June, …
At a quick glance, the Food and Drug Administration’s decision to ask its advisers for help in vetting yet another cancer immunotherapy may seem odd. …
Dive Brief: Eli Lilly is pushing back the timing for when it expects to finish submitting an application for U.S. approval of its experimental drug …
Dive Brief: The Food and Drug Administration on Tuesday granted approval to the first drug for a rare cancer of the eye that has spread …
