FDA

NuVasive’s Precice Limb Lengthening System Is Now an Option for Pediatric Patients
Xtalks
Tue, 04/18/23 - 10:14 pm
NuVasive
FDA
Medtech
Precice Limb Lengthening System
FDA expands Qulipta indication to include chronic migraine prevention
Healio
Tue, 04/18/23 - 10:13 pm
AbbVie
migraine
FDA
CGRP blockers
Qulipta
FDA says older adults and the immunocompromised may get a spring booster dose of Covid vaccine
Stat
Tue, 04/18/23 - 10:22 am
FDA
COVID-19
vaccines
elderly
Agenus Receives Fast Track Designation for Botensilimab and Balstilimab in Colorectal Cancer
Yahoo/Businesswire
Tue, 04/18/23 - 10:10 am
Agenus
immuno-oncology
fast track
FDA
botensilimab
balstilimab
Teva's Partner Alvotech Receives Complete Response Letter For AVT02 BLA
Business Insider
Mon, 04/17/23 - 11:06 pm
Teva Pharmaceutical
Alvotech
AVT02
FDA
Humira
biosimilars
How Gamida Cell’s FDA Approval Could Reduce Racial Disparities in Stem Cell Transplants
MedCity News
Mon, 04/17/23 - 10:54 pm
Gamida Cell
FDA
Omisirge
cell therapy
blood cancers
FDA to require new safety warnings for opioids
RAPS.org
Mon, 04/17/23 - 10:50 pm
FDA
regulatory
opioids
opioid crisis
Abbott gets clearance for Libre 3 reader, opening path to Medicare coverage
Medtech Dive
Mon, 04/17/23 - 12:38 pm
Abbott Labs
Medtech
continuous glucose monitoring
FreeStyle Libre 3
FDA
FDA advisers back Lundbeck and Otsuka's Rexulti in Alzheimer's disease agitation
Fierce Pharma
Sun, 04/16/23 - 11:17 pm
Lundbeck
Otsuka
Rexulti
Alzheimer's disease
FDA
FDA rejects Teva’s high-potency biosimilar of Humira again
Pharmaphorum
Fri, 04/14/23 - 10:37 am
Teva Pharmaceutical
Alvotech
biosimilars
FDA
Humira
Sarepta shares drop as report says FDA almost rejected under-review gene therapy
Yahoo/Reuters
Fri, 04/14/23 - 10:16 am
Sarepta Therapeutics
FDA
gene therapy
DMD
Duchenne Muscular Dystrophy
FDA declines to approve Eli Lilly's bowel disease drug
Yahoo/Reuters
Thu, 04/13/23 - 10:19 pm
Eli Lilly
IBD
FDA
mirikizumab
Appeals court rules abortion drug can stay on market — but limits access
BioPharma Dive
Thu, 04/13/23 - 12:00 pm
legal
abortion pill
FDA
mifepristone
FDA outlines risk-based approach to monitoring clinical trials
RAPS.org
Tue, 04/11/23 - 07:19 pm
clinical trials
regulatory
FDA
risk
Biopharma Rallies Behind FDA After Texas Abortion Pill Ruling
BioSpace
Tue, 04/11/23 - 11:44 am
biotech
FDA
Texas
legal
mifepristone
abortion pill
Chasing Pfizer and Roche, Regenxbio benefits from FDA boost for DMD gene therapy
Fierce Biotech
Tue, 04/11/23 - 11:32 am
Regenxbio
adeno-associated viruses
Duchenne Muscular Dystrophy
FDA
Caribou gets FDA fast track for allogeneic CAR-T
Biopharma Reporter
Tue, 04/11/23 - 10:02 am
Caribou Biosciences
FDA
Multiple Myeloma
CAR-T
CB-011
Biotech leaders 'cannot stay quiet' as judge blocks abortion pill approval
Fierce Biotech
Mon, 04/10/23 - 11:38 am
biotech
FDA
legal
abortion pill
mifepristone
Abbott glucose monitor readers could catch fire, FDA warns in recall notice
Stat
Fri, 04/7/23 - 01:46 pm
Abbott Labs
Medtech
FDA
product recalls
diabetes
blood glucose monitoring
FDA forces unproven premature birth drug Makena off market
The Hill
Thu, 04/6/23 - 11:40 am
Makena
premature birth
Covis Pharma
FDA

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