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AdCom · news · pharmadog
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News · AdCom
115
stories
22h
Opinion: Capricor’s Duchenne muscular dystrophy drug and the countless tiny decisions that can make or break a study
stat
1d
Trump picks White House aide Heidi Overton as FDA chief: Reports
biospace
2d
Physician group sues Trump administration over dietary guidelines process
stat
6d
Capricor, seeking lifeline for Duchenne therapy, says it will ask FDA to review additional data
endpoints
6d
Capricor soars on potential FDA review extension, filing amendments
biospace
6d
Capricor soars on plan to amend DMD filing after adcomm setback
fiercebiotech
8d
Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight
biospace
10d
STAT+: FDA panel to weigh Grail’s Galleri test
stat
13d
FDA to hold adcomm for Grail cancer test that failed in large, randomized trial
endpoints
13d
Replimune to ride wave of physician support to launch advanced melanoma therapy
biospace
14d
Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
biospace
14d
STAT+: FDA approves Replimune melanoma drug previously rejected twice
stat
14d
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
fda press
14d
Opinion: One year since Kennedy canceled mRNA vaccine projects, science shows how wrong he was
stat
14d
Moderna’s flu shot crosses FDA finish line, bouncing back from regulatory roadblock
biospace
14d
FDA approves Moderna’s mRNA flu vaccine
biopharma dive
15d
FDA approves Moderna’s mRNA flu vaccine, the first to use the technology
stat
15d
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
biospace
15d
Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms
biospace
20d
Capricor CEO won’t rule out legal action against FDA after negative adcomm
biospace
20d
Moderna maintains 10% growth target despite Phase 3 norovirus miss
biospace
20d
STAT+: Pharmalittle: We’re reading about a Novo setback, support for Replimune’s melanoma drug, and more
stat
20d
UniQure welcomes possible adcomm for Huntington’s asset as regulatory ‘jitters’ spread through biopharma
biospace
21d
This Week at FDA: ‘Simple reform’ reorg, adcomm updates, and more
raps
21d
Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
biospace
21d
Replimune scores win as FDA advisors back melanoma treatment
endpoints
21d
Capricor’s data clash and a fugitive in the C-suite
stat
21d
Replimune’s twice-rejected melanoma drug prevails in FDA adcomm
fiercebiotech
21d
STAT+: Pharmalittle: We’re reading about an FDA panel nixing a Duchenne drug, FTC suing Hims & Hers, and more
stat
21d
STAT+: FDA expert committee votes in favor of Replimune’s melanoma treatment
stat
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