Stephen Hahn went be­fore a Sen­ate com­mit­tee Wednes­day and de­clared he’s fight­ing. “Every one of the de­ci­sions we have reached has been made by ca­reer FDA sci­en­tists based on sci­ence and da­ta, not pol­i­tics,” he ex­claimed, adding that “FDA will not per­mit any pres­sure from any­one to change that. I will fight for sci­ence.”

A few hours lat­er, he was un­der­mined by Pres­i­dent Don­ald Trump when a re­porter asked if he was okay with stricter vac­cine guide­lines that the FDA was said to be cook­ing up. “That has to be ap­proved by the White House. We may or may not ap­prove it. That sounds like a po­lit­i­cal move,” he de­cid­ed.

The re­marks set up an­oth­er crit­i­cal junc­ture for the agency and its be­lea­guered com­mis­sion­er, who has been work­ing over­time to bol­ster pub­lic con­fi­dence in the FDA and his lead­er­ship since Hahn’s dis­as­trous per­for­mance as­sist­ing the pres­i­dent tout false con­va­les­cent plas­ma fig­ures.

The pres­i­dent then ques­tioned the need to length­en the ap­proval time­line, fore­cast­ing “great re­sults” ahead and again fram­ing the FDA’s moves as po­lit­i­cal:

Be­cause when you have Pfiz­er, John­son and John­son, Mod­er­na, these great com­pa­nies com­ing up with the vac­cines and they’ve done test­ing and every­thing else. I’m say­ing, why would they have to be adding great length to the process.

It sound­ed to me, ex­treme­ly po­lit­i­cal. Why would they do this, when we come back with these great re­sults. And I think you will have those great re­sults.

The new FDA stan­dards re­port­ed­ly passed muster at HHS on Tues­day and there was an ex­pec­ta­tion that it would get a green light from the White House, ac­cord­ing to a Politi­co re­port that cites two sources fa­mil­iar with the time­line. Trump re­port­ed­ly spoke with HHS sec­re­tary Alex Azar be­fore the press con­fer­ence.

Un­der the new guid­ance, vac­cine de­vel­op­ers must fol­low at least half the par­tic­i­pants for 60 days fol­low­ing the sec­ond dose, as well as ac­crue five or more cas­es of se­vere Covid-19 in the place­bo group, be­fore they can seek an EUA.

It’s still pos­si­ble the new EUA rules are al­lowed to go in­to ef­fect by Trump. But for an agency ac­cus­tomed to bi­par­ti­san def­er­ence from its po­lit­i­cal su­pe­ri­ors, it’s now sail­ing in un­chart­ed wa­ters work­ing un­der a pres­i­dent who de­mands key de­ci­sions be rout­ed through a com­mand-and-con­trol struc­ture firm­ly con­trolled by him or trust­ed lieu­tenants. And by hav­ing Trump la­bel their work as “ex­treme­ly po­lit­i­cal,” it rais­es new ques­tions on what mes­sag­ing, if any, FDA lead­ers can em­ploy that would both sat­is­fy the pres­i­dent and the sci­en­tif­ic com­mu­ni­ty.

Trump be­gan Wednes­day’s press con­fer­ence by en­cour­ag­ing Amer­i­cans to en­roll in Covid-19 vac­cine tri­als, and then tout­ed some ques­tion­ably star­ry num­bers on treat­ments in the pipeline. “We are see­ing promis­ing re­sults that are mon­o­clon­al an­ti­bod­ies which help the im­mune sys­tem fight the virus,” Trump said, halt­ing­ly read­ing a script.

But the first ques­tion he took was on the peace­ful trans­fer of pow­er af­ter the elec­tion. He re­fused to com­mit to it.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.