|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Some interesting FDA- and FDA-adjacent odds and ends we've tracked this week: 1) Former acting FDA commissioner and senior HHS advisor Sara Brenner has been selected to lead the White House Office of Pandemic Preparedness and Response, according to Bloomberg News. 2) In the House Rules Committee hearing on the Defense department's budget on Monday, Rep. Pete Sessions (R-TX) introduced an
amendment that would create a new government fund for early- mid-stage biotechs operating in the US. First introduced as a bill back in 2025, the amendment did not appear in the rule that the Committee reported out on Monday, according to a committee spokesperson. 2) In response to a citizen petition from several law firms, the FDA spells out in greater detail, in a response released Monday, why it decided to authorize the new drug import program for Colorado. 3) With regard to the FDA's request for information on repurposing drugs for unmet needs, the agency has received more than 500 comments. |
|
|
|
Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
|
|
|
|
|
|
|
by Max Bayer
|
Under new leadership, FDA officials have said they’ll place renewed emphasis on advisory meetings for contested product applications. Two new announcements suggest they’re making good... | |
|
|
|
|
|
|
by Zachary Brennan
|
Vijay Kumar is leaving his role as acting director of CBER's Office of Therapeutic Products and will soon consider options both inside and outside the... | |
|
|
|
|
|
|
by Drew Armstrong
|
A congressional committee has opened an inquiry into Bristol Myers Squibb and Pfizer's use of clinical trial sites in China, including facilities that the committee's... | |
|
|
|
|
|
|
by Shelby Livingston
|
Ahead of an FDA advisory committee meeting to discuss lifting restrictions on seven popular peptides, agency reviewers have recommended against including the peptides on a... | |
|
|
|
|
|
|
by Anna Brown
|
The FDA has chosen the first seven companies to participate in its PreCheck pilot program, a group that includes large drugmakers Eli Lilly and Regeneron... | |
|
|
|
|
|
|
by Nicole DeFeudis
|
Pivotal data for Amgen’s Tavneos have been retracted from the New England Journal of Medicine, creating another obstacle for the beleaguered autoimmune drug. Two academic... | |
|
|
|
|
|
