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AdCom · news · pharmadog
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News · AdCom
169
stories
Aug 7, 26
FDA to hold adcomm for Grail cancer test that failed in large, randomized trial
endpoints
Aug 7, 26
Replimune to ride wave of physician support to launch advanced melanoma therapy
biospace
Aug 6, 26
Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
biospace
Aug 6, 26
STAT+: FDA approves Replimune melanoma drug previously rejected twice
stat
Aug 6, 26
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
fda press
Aug 6, 26
Opinion: One year since Kennedy canceled mRNA vaccine projects, science shows how wrong he was
stat
Aug 6, 26
Moderna’s flu shot crosses FDA finish line, bouncing back from regulatory roadblock
biospace
Aug 6, 26
FDA approves Moderna’s mRNA flu vaccine
biopharma dive
Aug 6, 26
FDA approves Moderna’s mRNA flu vaccine, the first to use the technology
stat
Aug 5, 26
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
biospace
Aug 5, 26
Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms
biospace
Jul 31, 26
Capricor CEO won’t rule out legal action against FDA after negative adcomm
biospace
Jul 31, 26
Moderna maintains 10% growth target despite Phase 3 norovirus miss
biospace
Jul 31, 26
STAT+: Pharmalittle: We’re reading about a Novo setback, support for Replimune’s melanoma drug, and more
stat
Jul 31, 26
UniQure welcomes possible adcomm for Huntington’s asset as regulatory ‘jitters’ spread through biopharma
biospace
Jul 31, 26
This Week at FDA: ‘Simple reform’ reorg, adcomm updates, and more
raps
Jul 30, 26
Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
biospace
Jul 30, 26
Replimune scores win as FDA advisors back melanoma treatment
endpoints
Jul 30, 26
Capricor’s data clash and a fugitive in the C-suite
stat
Jul 30, 26
Replimune’s twice-rejected melanoma drug prevails in FDA adcomm
fiercebiotech
Jul 30, 26
STAT+: Pharmalittle: We’re reading about an FDA panel nixing a Duchenne drug, FTC suing Hims & Hers, and more
stat
Jul 30, 26
STAT+: FDA expert committee votes in favor of Replimune’s melanoma treatment
stat
Jul 30, 26
Recon: FDA adcomm votes against Capricor’s DMD drug; Cytokinetics gets UK approval, NICE backing for heart drug
raps
Jul 29, 26
FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
biospace
Jul 29, 26
FDA reviewers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
biospace
Jul 29, 26
Capricor Duchenne cell therapy voted down by FDA panel
biopharma dive
Jul 29, 26
Updated: FDA adcomm votes down Capricor's DMD therapy over efficacy
endpoints
Jul 29, 26
FDA adcomm shoots down Capricor's Duchenne cell therapy after meeting marked by statistical dispute
fiercebiotech
Jul 29, 26
NYU's Neil Vasan departs as acting chair of FDA's cancer drug advisory panel
endpoints
Jul 29, 26
FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer’s data
biopharma dive
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