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» complete response letter
complete response letter
Sarepta Duchenne drug rejected by FDA in surprise decision
Biopharma Dive
Mon, 08/19/19 - 11:48 pm
Sarepta Therapeutics
Duchenne Muscular Dystrophy
FDA
complete response letter
Vyondys 53
Teva, Pfizer Seek Clarity on Tentative ANDA Approval Draft Guidance
RAPS.org
Tue, 04/2/19 - 11:31 pm
Pfizer
Teva Pharmaceutical
FDA
complete response letter
Evoke Pharma Plunges After FDA Issues CRL for Gimotti
BioSpace
Tue, 04/2/19 - 12:06 pm
Evoke Pharma
FDA
complete response letter
Gimotti
gastroparesis
Recro Pharma Receives Complete Response Letter from the FDA for Intravenous Meloxicam
Recro Pharma
Sat, 03/23/19 - 11:45 am
Recro Pharma
complete response letter
FDA
meloxicam
painkillers
Liver toxicity concerns spike Motif Bio’s iclaprim filing
Fierce Biotech
Thu, 02/14/19 - 05:55 pm
FDA
Motif Biosciences
ABSSSI
Iclaprim
complete response letter
Sunovion Receives Complete Response Letter from FDA for Parkinson’s Disease Drug
CP Wire
Thu, 01/31/19 - 10:23 am
Sunovion
Parkinson's Disease
apomorphine sublingual film
APL-130277
FDA
complete response letter
Putting the “Complete” Back into Complete Response Letters
FDA Law Blog
Sat, 10/27/18 - 12:03 pm
FDA
complete response letter
FDA kicks Regeneron’s latest Eylea application to the curb, but they’re not sweating it
Endpoints
Thu, 10/25/18 - 09:56 am
Regeneron
FDA
Eylea
complete response letter
The pain won’t stop. GSK ends the week with a slapdown on its Nucala application for COPD
Endpoints
Fri, 09/7/18 - 06:34 pm
GSK
Nucala
FDA
complete response letter
COPD
Sunovion Receives Bad News From the FDA About ADHD Drug
CP Wire
Fri, 08/31/18 - 10:45 am
Sunovion
CRL
NDA
dasotraline
ADHD
FDA
complete response letter
Sunovion Receives Bad News From the FDA About ADHD Drug
Fri, 08/31/18 - 10:42 am
Sunovion
complete response letter
dasotraline
ADHD
GSK wins yet another reprieve for blockbuster Advair franchise as Mylan is hit (again) with a CRL
Endpoints
Thu, 06/14/18 - 09:59 am
Mylan
FDA
Advair
GSK
complete response letter
FDA stalls yet another Herceptin copycat, issuing response letter to Amgen/Allergan
Endpoints
Fri, 06/1/18 - 10:40 pm
Amgen
Allergan
FDA
complete response letter
biosimilars
Herceptin
ABP 980
Are small companies carrying the complete response letter can?
EP Vantage
Thu, 05/24/18 - 10:04 pm
FDA
complete response letter
Recro Pharma
Cosmo Pharma
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