complete response letter

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv
Fierce Pharma
Tue, 02/28/23 - 10:51 pm
Cytokinetics
heart failure
FDA
complete response letter
Omecamtiv Mecarbil
Acadia hits another Nuplazid roadblock as the FDA doles out CRL and recommends another trial
Endpoints
Fri, 08/5/22 - 10:51 am
Acadia Pharmaceuticals
Nuplazid
FDA
complete response letter
Alzheimer's disease psychosis
Rare disease outfit Acer fumbles at FDA, receiving CRL due to lack of inspection readiness at packaging manufacturer
Endpoints
Tue, 06/21/22 - 11:02 am
Acer Therapeutics
ACER-001
urea cycle disorders
FDA
complete response letter
It's CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News
BioSpace
Mon, 05/2/22 - 11:44 am
FDA
complete response letter
Junshi Biosciences
Coherus Biosciences
Axsome Therapeutics
migraines
AXS-07
Teva receives CRL for reformulated schizophrenia drug developed with French biotech
Endpoints
Wed, 04/20/22 - 10:48 am
Teva Pharmaceutical
MedinCell
schizophrenia
FDA
complete response letter
Tiny pharma hits a new low with FDA refusing to review company's response to its CRL
Endpoints
Tue, 02/22/22 - 10:57 am
Zosano Pharma
FDA
complete response letter
migraines
migraine patch
FDA denies Ardelyx’s appeal against kidney drug rejection, hammering another nail in tenapanor’s coffin
Fierce Biotech
Thu, 02/10/22 - 10:30 am
Ardelyx
FDA
complete response letter
tenapanor
chronic kidney disease
Regulatory rejection flurry does not make a storm
EP Vantage
Fri, 10/22/21 - 12:07 pm
FDA
complete response letter
regulatory
The clock is ticking for Iterum after FDA hands down CRL for Pfizer castoff antibiotic
Endpoints
Mon, 07/26/21 - 10:04 pm
FDA
complete response letter
Iterum
Pfizer
antibiotics
sulopenem
Can a CRL Be Final Agency Action: One Step Closer to Finding Out
FDA Law Blog
Tue, 07/6/21 - 11:35 pm
FDA
complete response letter
Provention Bio slapped with FDA rejection for diabetes hopeful teplizumab
Fierce Biotech
Tue, 07/6/21 - 10:58 am
Provention Bio
FDA
teplizumab
type 1 diabetes
complete response letter
FDA Refuses to Approve Novartis' $9.7 Billion Cholesterol Drug for Now
Motley Fool
Sat, 12/19/20 - 11:41 pm
Novartis
FDA
cholesterol
inclisiran
complete response letter
FDA gives thumbs-down on hearing loss drug, citing manufacturing issues, and sends Fennec stock reeling
Endpoints
Tue, 08/11/20 - 12:37 pm
Fennec
Pedmark
FDA
hearing loss
complete response letter
FDA bars the door — for now — against Merck’s star cancer drug after Roche beat them to the punch
Endpoints
Wed, 07/8/20 - 10:43 am
Merck
FDA
complete response letter
Keytruda
Eisaid
Lenvima
hepatocellular carcinoma
Roche
Heron's wings clipped again with another FDA rejection for opioid alternative
Fierce Biotech
Mon, 06/29/20 - 10:02 am
Heron Therapeutics
complete response letter
FDA
non-opioid pain treatments
HTX-011
After a PhIII failure, the FDA delivers Blueprint an expected CRL
Endpoints
Fri, 05/15/20 - 10:37 am
Blueprint Medicines
FDA
complete response letter
Ayvakit
gastrointestinal stromal tumors
FDA makes it official, once again rejecting battered Correvio’s heart drug
Endpoints
Mon, 12/30/19 - 09:55 am
FDA
complete response letter
Correvio
Vernakalant
atrial fibrillation
FDA slams GSK's monthly HIV injectable with CRL, citing manufacturing issues
Endpoints
Mon, 12/23/19 - 11:44 pm
FDA
complete response letter
GSK
HIV
cabotegravir
rilpivirine
Time for FDA to Release Complete Responses Letters? Debate Reignites
RAPS.org
Sun, 08/25/19 - 05:03 pm
FDA
transparency
complete response letter
Vanda Pharmaceuticals “perplexed” by FDA rejection of jet lag drug
Pharmaforum
Tue, 08/20/19 - 10:09 am
Vanda Pharmaceuticals
FDA
jet lag
Hetlioz
complete response letter

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