complete response letter

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv
FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv
Fierce Pharma
Cytokinetics
heart failure
FDA
complete response letter
Omecamtiv Mecarbil
Flag link:
Acadia hits another Nuplazid roadblock as the FDA doles out CRL and recommends another trial
Acadia hits another Nuplazid roadblock as the FDA doles out CRL and recommends another trial
Endpoints
Acadia Pharmaceuticals
Nuplazid
FDA
complete response letter
Alzheimer's disease psychosis
Flag link:
Rare disease outfit Acer fumbles at FDA, receiving CRL due to lack of inspection readiness at packaging manufacturer
Rare disease outfit Acer fumbles at FDA, receiving CRL due to lack of inspection readiness at packaging manufacturer
Endpoints
Acer Therapeutics
ACER-001
urea cycle disorders
FDA
complete response letter
Flag link:
It's CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News
It's CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News
BioSpace
FDA
complete response letter
Junshi Biosciences
Coherus Biosciences
Axsome Therapeutics
migraines
AXS-07
Flag link:
Teva receives CRL for reformulated schizophrenia drug developed with French biotech
Teva receives CRL for reformulated schizophrenia drug developed with French biotech
Endpoints
Teva Pharmaceutical
MedinCell
schizophrenia
FDA
complete response letter
Flag link:
Tiny pharma hits a new low with FDA refusing to review company's response to its CRL
Tiny pharma hits a new low with FDA refusing to review company's response to its CRL
Endpoints
Zosano Pharma
FDA
complete response letter
migraines
migraine patch
Flag link:
FDA denies Ardelyx’s appeal against kidney drug rejection, hammering another nail in tenapanor’s coffin
FDA denies Ardelyx’s appeal against kidney drug rejection, hammering another nail in tenapanor’s coffin
Fierce Biotech
Ardelyx
FDA
complete response letter
tenapanor
chronic kidney disease
Flag link:
Regulatory rejection flurry does not make a storm
Regulatory rejection flurry does not make a storm
EP Vantage
FDA
complete response letter
regulatory
Flag link:
The clock is ticking for Iterum after FDA hands down CRL for Pfizer castoff antibiotic
The clock is ticking for Iterum after FDA hands down CRL for Pfizer castoff antibiotic
Endpoints
FDA
complete response letter
Iterum
Pfizer
antibiotics
sulopenem
Flag link:
Can a CRL Be Final Agency Action: One Step Closer to Finding Out
Can a CRL Be Final Agency Action: One Step Closer to Finding Out
FDA Law Blog
FDA
complete response letter
Flag link:
Provention Bio slapped with FDA rejection for diabetes hopeful teplizumab
Provention Bio slapped with FDA rejection for diabetes hopeful teplizumab
Fierce Biotech
Provention Bio
FDA
teplizumab
type 1 diabetes
complete response letter
Flag link:
FDA Refuses to Approve Novartis' $9.7 Billion Cholesterol Drug for Now
FDA Refuses to Approve Novartis' $9.7 Billion Cholesterol Drug for Now
Motley Fool
Novartis
FDA
cholesterol
inclisiran
complete response letter
Flag link:
FDA gives thumbs-down on hearing loss drug, citing manufacturing issues, and sends Fennec stock reeling
FDA gives thumbs-down on hearing loss drug, citing manufacturing issues, and sends Fennec stock reeling
Endpoints
Fennec
Pedmark
FDA
hearing loss
complete response letter
Flag link:
FDA bars the door — for now — against Merck’s star cancer drug after Roche beat them to the punch
FDA bars the door — for now — against Merck’s star cancer drug after Roche beat them to the punch
Endpoints
Merck
FDA
complete response letter
Keytruda
Eisaid
Lenvima
hepatocellular carcinoma
Roche
Flag link:
Heron's wings clipped again with another FDA rejection for opioid alternative
Heron's wings clipped again with another FDA rejection for opioid alternative
Fierce Biotech
Heron Therapeutics
complete response letter
FDA
non-opioid pain treatments
HTX-011
Flag link:
After a PhIII failure, the FDA delivers Blueprint an expected CRL
After a PhIII failure, the FDA delivers Blueprint an expected CRL
Endpoints
Blueprint Medicines
FDA
complete response letter
Ayvakit
gastrointestinal stromal tumors
Flag link:
FDA makes it official, once again rejecting battered Correvio’s heart drug
FDA makes it official, once again rejecting battered Correvio’s heart drug
Endpoints
FDA
complete response letter
Correvio
Vernakalant
atrial fibrillation
Flag link:
FDA slams GSK's monthly HIV injectable with CRL, citing manufacturing issues
FDA slams GSK's monthly HIV injectable with CRL, citing manufacturing issues
Endpoints
FDA
complete response letter
GSK
HIV
cabotegravir
rilpivirine
Flag link:
Time for FDA to Release Complete Responses Letters? Debate Reignites
Time for FDA to Release Complete Responses Letters? Debate Reignites
RAPS.org
FDA
transparency
complete response letter
Flag link:
Vanda Pharmaceuticals “perplexed” by FDA rejection of jet lag drug
Vanda Pharmaceuticals “perplexed” by FDA rejection of jet lag drug
Pharmaforum
Vanda Pharmaceuticals
FDA
jet lag
Hetlioz
complete response letter
Flag link:

Pages