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CRL (Complete Response Letter) · news · pharmadog
← back to CRL (Complete Response Letter)
News · CRL (Complete Response Letter)
52
stories
5d
Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again
biospace
14d
Analysts ‘extremely bullish’ as Telix beams into Novartis’ territory with $1.6B ITM acquisition
fiercebiotech
Aug 24, 26
REGENXBIO’s Hunter syndrome gene therapy hit by FDA hold, stymieing resubmission plans
biospace
Aug 20, 26
Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision
biospace
Aug 20, 26
Medigen links up with Charles River in push to take enterovirus vaccine global
fiercebiotech
Aug 19, 26
Trump picks White House aide Heidi Overton as FDA chief: Reports
biospace
Aug 14, 26
Nascent US psychedelic therapy opportunity attracts overseas manufacturers
biospace
Aug 11, 26
FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues
biospace
Aug 10, 26
ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualms
fiercebiotech
Aug 10, 26
Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug
fiercebiotech
Aug 6, 26
Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
biospace
Aug 5, 26
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
biospace
Jul 30, 26
Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
biospace
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 28, 26
FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
biospace
Jul 27, 26
Summit, Merck must navigate new regulatory terrain in China-first cancer landscape
biospace
Jul 27, 26
FDA has recommitted to adcomms—but to what end?
biospace
Jul 23, 26
Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbump
biospace
Jul 22, 26
Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2
biospace
Jul 20, 26
FDA’s radical transparency policy for rejections runs into legal uncertainty
biospace
Jul 13, 26
Tris Pharma's CRL for narcolepsy drug; Agenus abandons Phase 3 CRC trial
endpoints
Jul 10, 26
FDA returns to releasing pharma rejection letters with 14 new CRLs
endpoints
Jul 9, 26
FDA quietly stops releasing CRLs
endpoints
Jul 2, 26
Galderma gets CRL for anti-wrinkle drug; Kimball buys CDMO for $103M
endpoints
Jun 30, 26
Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program
biopharma dive
Jun 30, 26
Unicycive gets second CRL for kidney drug as manufacturing woes continue
endpoints
Jun 17, 26
FDA gives rejected drugs another chance in post-Makary era
endpoints
Jun 11, 26
Camurus’ second CRL for acromegaly drug; Teva details workforce cuts
endpoints
Jun 4, 26
Hikma to funnel $267M to Ohio; Cingulate gets CRL for ADHD drug
endpoints
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