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AdCom · news · pharmadog
← back to AdCom
News · AdCom
169
stories
Jul 29, 26
Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
biospace
Jul 29, 26
STAT+: FDA expert panel recommends against approval of Capricor’s Duchenne drug
stat
Jul 28, 26
FDA reminds investors about the risks of advisory panels
endpoints
Jul 28, 26
FDA staff say Replimune's melanoma trial failed to prove RP1 works
endpoints
Jul 28, 26
The future of gray-market peptides
endpoints
Jul 28, 26
STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
stat
Jul 28, 26
FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
biospace
Jul 27, 26
Capricor's DMD therapy lacks efficacy, FDA says ahead of adcomm
endpoints
Jul 27, 26
Six wellness peptides win backing from FDA advisory committee
endpoints
Jul 27, 26
UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy
biospace
Jul 27, 26
FDA scientists question Capricor data; Legend CEO steps down
biopharma dive
Jul 27, 26
STAT+: Pharmalittle: We’re reading about a U.S. peptide panel’s votes, Amgen scuffling with the FDA, and more
stat
Jul 27, 26
FDA has recommitted to adcomms—but to what end?
biospace
Jul 27, 26
EMA says it takes ultimate responsibility for protecting online meeting registration, survey information
raps
Jul 24, 26
Opinion: I led the FDA’s food safety and nutrition center. Here’s what people are missing about the cyclospora outbreak
stat
Jul 24, 26
FDA advisory panel narrowly rejects compounding of one peptide, backs two others
stat
Jul 24, 26
STAT+: Pharmalittle: We’re reading about an FDA panel and peptides, a Merck license for an HIV pill, and more
stat
Jul 24, 26
A new, separate outbreak of the diarrhea-causing parasite
stat
Jul 24, 26
FDA panel endorses broader use of certain peptides
biopharma dive
Jul 24, 26
This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
raps
Jul 24, 26
FDA advisory committee backs two more peptides, rejects one for compounding list
raps
Jul 23, 26
STAT+: In win for RFK Jr., FDA advisory panel narrowly votes to allow compounding of unapproved peptides
stat
Jul 23, 26
Updated: FDA adcomm backs popular wellness peptides, despite staff concerns
endpoints
Jul 23, 26
FDA panel confronting peptide controversy
stat
Jul 23, 26
Study: Most sponsors complete postmarketing trials, publish results
raps
Jul 23, 26
FDA advisory committee backs two controversial peptides
raps
Jul 21, 26
Notes from a peptide meetup
endpoints
Jul 21, 26
Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
biospace
Jul 20, 26
HHS vaccine committee quietly gets new charter
stat
Jul 18, 26
‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics
fiercebiotech
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