CRL

Incyte hit by CRL on extended-release JAK tablets, muddying plans for Jakafi franchise expansion
Endpoints
Fri, 03/24/23 - 10:05 am
Incyte
FDA
ruxolitinib
CRL
Alkermes is handed a CRL for ‘3831, marking another setback on the R&D front
Endpoints
Tue, 11/17/20 - 10:48 am
Alkermes
ALKS-3831
FDA
CRL
Penny stock player Adamis gets another CRL for high-dose naloxone as shares crater
Endpoints
Tue, 11/17/20 - 10:47 am
Adamis Pharmaceuticals
Naloxone
CRL
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
Mylan and Biocon biosimilar of Amgen’s Neulasta hit with manufacturing-related CRL
Fierce Pharma
Tue, 10/10/17 - 10:18 am
Mylan Labs
Biocon
Amgen
Neulasta
CRL
FDA
biosimilars
Valeant gets 2nd CRL for eye drug, stung again by manufacturing failings
Fierce Pharma
Wed, 08/9/17 - 09:33 am
Valeant Pharmaceuticals
CRL
latanoprostene bunod
open angle glaucoma
The complete response letter: The mail no one wants to receive
Chemical Engineering News
Mon, 05/15/17 - 01:31 pm
FDA
CRL
drug approvals
FDA hits Nicox with CRL on eye drug application
BioPharma Dive
Tue, 10/11/16 - 09:27 pm
NicOx
FDA
CRL
AC-170
allergic conjunctivitis