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PDUFA · news · pharmadog
← back to PDUFA
News · PDUFA
41
stories
1d
Opinion: FDA must ensure American patients can access new and experimental drugs
biospace
4d
Sarepta could be ‘potential turnaround story’ with catalysts lined up into 2027
biospace
6d
Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again
biospace
19d
Graham: PDUFA VIII reflects ‘America First’ principles
raps
20d
FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival
biospace
21d
Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting
biospace
25d
FDA delays approval decision for Exelixis' tyrosine kinase inhibitor in colorectal cancer
fiercebiotech
25d
In first interview as FDA oncology chief, Angelo de Claro vows to ‘continue the innovation’ behind OCE legacy
fiercebiotech
26d
For PDUFA VIII, the most valuable incentive may be time
biospace
27d
BMS clinches pivotal win for myeloma CAR T in ‘key derisking event’
biospace
28d
AstraZeneca’s SERD pill overcomes adcomm defeat to win FDA nod in breast cancer
biospace
Sep 3, 26
FDA approves Ionis’ antisense drug as first targeted therapy for Alexander disease
biospace
Sep 3, 26
Ultragenyx fails phase 3 Angelman test, plots ‘significant expense reductions’
fiercebiotech
Sep 2, 26
UniQure files for FDA, UK approval of first gene therapy for Huntington’s disease
biospace
Aug 28, 26
Teva saddles up as stalking horse bidder for bankrupt BioXcel’s neuroscience portfolio
fiercebiotech
Aug 26, 26
Summit, Akeso tout biliary cancer win for PD-1/VEGF in China—but details are pending
biospace
Aug 26, 26
Capricor’s DMD therapy still alive, Merck/Moderna’s cancer vax shines, FDA’s future revealed
biospace
Aug 24, 26
Capricor’s Duchenne therapy has new life after FDA grants 3-month extension
biospace
Aug 24, 26
FDA delays Capricor's deramiocel PDUFA date to review new data
endpoints
Aug 24, 26
Capricor, Replimune reviews signal FDA’s return to reliability but every application will stand alone
biospace
Aug 21, 26
Capricor investor calls for change as company awaits decision on Duchenne candidate
biospace
Aug 14, 26
Capricor soars on potential FDA review extension, filing amendments
biospace
Aug 14, 26
Capricor soars on plan to amend DMD filing after adcomm setback
fiercebiotech
Aug 13, 26
PDUFA VIII commitments: 'America First' provisions, faster reviews and more
endpoints
Aug 13, 26
PDUFA VIII: FDA outlines goals, program enhancements in commitment letter
raps
Aug 12, 26
Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight
biospace
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
Aug 4, 26
Vertex unfazed by competitive IgAN space as FDA verdict looms
biospace
Jul 31, 26
Capricor CEO won’t rule out legal action against FDA after negative adcomm
biospace
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