advisory panels

Paratek clears one last big hurdle on the way to an FDA marketing decision for antibiotic
Paratek clears one last big hurdle on the way to an FDA marketing decision for antibiotic
Endpoints
Paratek
antibiotics
omadacycline
FDA
advisory panels
Flag link:
FDA advisory panel turns down PneumRx’s Elevair lung implant
FDA advisory panel turns down PneumRx’s Elevair lung implant
Fierce Biotech
FDA
advisory panels
PneumRx
Elevair
lung implants
emphysema
Flag link:
Rejected: After paying $80M to acquire it, Mallinckrodt’s jaundice drug snubbed by FDA’s advisory committee
Rejected: After paying $80M to acquire it, Mallinckrodt’s jaundice drug snubbed by FDA’s advisory committee
Endpoints
Mallinckrodt
FDA
advisory panels
infantile jaundice
InfaCare
stannsoporfin
Flag link:
FDA Panel Splits on Lilly Arthritis Drug, Backs Lower of Two Doses
FDA Panel Splits on Lilly Arthritis Drug, Backs Lower of Two Doses
Xconomy
Eli Lilly
FDA
advisory panels
rheumatoid arthritis
baricitinib
Incyte
Flag link:
FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy
FDA Panel Votes To Approve Marijuana-Based Drug For Epilepsy
Forbes
FDA
GW Pharma
Epidiolex
epilepsy
advisory panels
Flag link:
Pfizer Gets FDA Panel Backing for New Indication for Xeljanz
Pfizer Gets FDA Panel Backing for New Indication for Xeljanz
Yahoo/Zacks.com
Pfizer
FDA
advisory panels
Xeljanz
ulcerative colitis
Flag link:
FDA advisory group rejects Pacira’s pitch for expanded use of pain drug
FDA advisory group rejects Pacira’s pitch for expanded use of pain drug
Endpoints
FDA
advisory panels
Pacira
pain block
anesthesia
Flag link:
Aradigm crashes after FDA panel votes down antibiotic
Aradigm crashes after FDA panel votes down antibiotic
Fierce Biotech
Aradigm
FDA
advisory panels
antibiotics
Linhaliq
Flag link:
Why an FDA Panel Shot Down Intrinsic's Spinal Implant
Why an FDA Panel Shot Down Intrinsic's Spinal Implant
Medical Devices and Diagnostics Industry
FDA
advisory panels
devices
Intrinsic Therapeutics
spinal implants
Barracaid
Flag link:
FDA panel votes yes on Indivior’s opioid addiction drug
FDA panel votes yes on Indivior’s opioid addiction drug
Endpoints
FDA
advisory panels
Indivior
opioid addiction
RBP-6000
buprenorphine
Flag link:
FDA advisory committee backs Aerie’s Rhopressa eye drug
FDA advisory committee backs Aerie’s Rhopressa eye drug
Drug Delivery Business News
Aerie Pharma
Rhopressa
FDA
Open-Angle Glaucoma
ocular hypertension
advisory panels
Flag link:
Spark’s Gene Therapy to Restore Vision Wins Unanimous FDA Panel Vote
Spark’s Gene Therapy to Restore Vision Wins Unanimous FDA Panel Vote
Xconomy
Spark Therapeutics
gene therapy
FDA
advisory panels
Luxturna
Flag link:
J&J set back by negative panel vote for sirukumab
J&J set back by negative panel vote for sirukumab
BioPharma Dive
JNJ
FDA
sirukumab
advisory panels
rheumatoid arthritis
Flag link:
Data supports safety of Dynavax hepatitis B vaccine -U.S. FDA panel
Data supports safety of Dynavax hepatitis B vaccine -U.S. FDA panel
Yahoo/Reuters
Dynavax
vaccines
hepatitis B
Heplisav
FDA
advisory panels
Flag link:
Novartis wins unanimous support from FDA panel on groundbreaking CAR-T med
Novartis wins unanimous support from FDA panel on groundbreaking CAR-T med
Fierce Pharma
Novartis
CAR-T
FDA
advisory panels
CTL019
Flag link:
FDA panel to focus on safety of Novartis gene therapy drug
FDA panel to focus on safety of Novartis gene therapy drug
Yahoo/Reuters
FDA
advisory panels
Novartis
gene therapy
CAR-T
acute lymphoblastic leukemia
Flag link:
FDA panel supports cardiovascular indication for Novo’s diabetes drug Victoza
FDA panel supports cardiovascular indication for Novo’s diabetes drug Victoza
Fierce Pharma
FDA
advisory panels
Novo Nordisk
diabetes
Victoza
Flag link:
July 12 FDA panel review looms as a watershed moment in Novartis’ campaign to win an historic new drug OK
July 12 FDA panel review looms as a watershed moment in Novartis’ campaign to win an historic new drug OK
Endpoints
Novartis
FDA
CAR-T
advisory panels
CTL019
pediatric B-cell acute lymphoblastic leukemia
Flag link:
FDA panel backs Pfizer biosim to blockbuster anemia meds from Amgen, Johnson & Johnson
FDA panel backs Pfizer biosim to blockbuster anemia meds from Amgen, Johnson & Johnson
Fierce Pharma
FDA
advisory panels
Pfizer
biosimilars
Amgen
Epogen
Procrit
anemia
JNJ
Flag link:
FDA Panel Votes 12 To 4 to Approve Puma's Breast Cancer Drug
FDA Panel Votes 12 To 4 to Approve Puma's Breast Cancer Drug
Forbes
FDA
Puma Biotechnology
breast cancer
advisory panels
neratinib
Flag link:

Pages