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PDUFA · news · pharmadog
← back to PDUFA
News · PDUFA
20
stories
6d
Capricor soars on potential FDA review extension, filing amendments
biospace
6d
Capricor soars on plan to amend DMD filing after adcomm setback
fiercebiotech
7d
PDUFA VIII commitments: 'America First' provisions, faster reviews and more
endpoints
8d
PDUFA VIII: FDA outlines goals, program enhancements in commitment letter
raps
8d
Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight
biospace
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
16d
Vertex unfazed by competitive IgAN space as FDA verdict looms
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
22d
FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
biospace
22d
FDA reviewers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
biospace
22d
Novo ordered to face CagriSema fraud claims from shareholders: New Jersey court
biospace
22d
Biotechs bring big launches and pharma rivalries into Q2 earnings period
biospace
24d
UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy
biospace
24d
FDA has recommitted to adcomms—but to what end?
biospace
Jul 21, 26
Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
biospace
Jul 20, 26
Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
biospace
May 27, 26
AstraZeneca's breast cancer PDUFA delayed; Arrowhead aims at same obesity target as Wave
endpoints
May 9, 26
The OncFive: Top Oncology Articles for the Week of 5/3
onclive
