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CRL (Complete Response Letter) · news · pharmadog
← back to CRL (Complete Response Letter)
News · CRL (Complete Response Letter)
48
stories
1d
Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision
biospace
2d
Trump picks White House aide Heidi Overton as FDA chief: Reports
biospace
7d
Nascent US psychedelic therapy opportunity attracts overseas manufacturers
biospace
10d
FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues
biospace
11d
ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualms
fiercebiotech
11d
Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug
fiercebiotech
14d
Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
biospace
16d
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad
biospace
21d
Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
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
24d
FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
biospace
25d
Summit, Merck must navigate new regulatory terrain in China-first cancer landscape
biospace
25d
FDA has recommitted to adcomms—but to what end?
biospace
29d
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
May 8, 26
UT MD Anderson Shares Latest Research Breakthroughs
onclive
May 8, 26
Giants of Cancer Care Announces the 14th Annual Class of Inductees
onclive
May 8, 26
OncLive Weekly News Quiz (5/8/2026): Test Your Knowledge on Key Breast, Lung, and Pancreatic Cancer Updates
onclive
May 8, 26
OncLive Polls Reveal Picks for Top Lung Cancer Abstracts at ASCO 2026
onclive
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