FDA

FDA Pauses Verve’s Trial Plan for Gene-Editing Therapy for High Cholesterol
MedCity News
Mon, 11/7/22 - 05:17 pm
Verve Therapeutics
gene editing
FDA
heterozygous familial hypercholesterolemia
VERVE-101
HeFH
Akebia Stands by Anemia in CKD Drug in Dispute Resolution Request
BioSpace
Mon, 11/7/22 - 10:48 am
Akebia Therapeutica
FDA
vadadustat
chronic kidney disease
FDA finalizes umbrella trial guidance for cell and gene therapies
RAPS.org
Sun, 11/6/22 - 01:28 pm
FDA
regulatory
clinical trials
umbrella trials
gene therapy
cell therapy
Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma
Drugs.com
Fri, 11/4/22 - 11:03 am
Pfizer
elranatamab
FDA
breakthrough therapy
relapsed or refractory multiple myeloma
FDA still not ready to go back to actual in-person meetings with biopharma sponsors
Endpoints
Thu, 11/3/22 - 07:22 pm
FDA
regulatory
COVID-19
pandemic
Sponsors need to maintain robust oversight of CROs to avoid FDA enforcement action
RAPS.org
Thu, 11/3/22 - 07:19 pm
FDA
regulatory
CROs
With FDA decision penciled in for May, GSK powers ahead in RSV race with Pfizer
Fierce Biotech
Wed, 11/2/22 - 10:25 am
GSK
Pfizer
RSV
vaccines
FDA
FDA chief stands by Paxlovid nod amid discussion on 'rebound' cases
Fierce Pharma
Wed, 11/2/22 - 10:18 am
Pfizer
Paxlovid
antivirals
COVID-19
FDA
Robert Califf
FDA Commissioner Robert Califf plans to keep tweeting amid Elon Musk upheaval
Medical Marketing and Media
Tue, 11/1/22 - 07:05 pm
FDA
social media
twitter
Robert Cliff
Elon Musk
NeuroOne Tried Again – And Succeeded
Medical Devices and Diagnostics Industry
Tue, 11/1/22 - 07:04 pm
Medtech
devices
NeuroOne
sEEG
FDA
brain mapping
After promising trial results for maternal RSV vaccine, Pfizer says it will seek FDA approval this year
CNN
Tue, 11/1/22 - 12:12 pm
Pfizer
vaccines
RSV
maternal vaccines
clinical trials
FDA
ASN to Spotlight Debate around Ardelyx's Embattled CKD Drug
BioSpace
Tue, 11/1/22 - 11:56 am
Ardelyx
FDA
tenapanor
chronic kidney disease
FDA again delays review of Amicus rare disease drug
BioPharma Dive
Mon, 10/31/22 - 04:11 pm
Amicus Therapeutics
Pompe disease
China
FDA
AT-GAA
Y-mAbs' rare disease drug roundly rejected by FDA AdComm over weakness of single-arm trial
Fierce Biotech
Mon, 10/31/22 - 10:27 am
Y-mAbs Therapeutics
FDA
omburtamab
pediatric neuroblastoma
This Week at FDA: Califf considering diagnostic reform rulemaking, Ashley says goodbye
RAPS.org
Sun, 10/30/22 - 04:20 pm
FDA
regulatory
Robert Califf
diagnostics
Medtech
Gilead's Hopes for HDV Approval Delayed after CRL
BioSpace
Sun, 10/30/22 - 04:15 pm
Gilead Sciences
hepatitis D
FDA
buleviritide
Santhera seeks speedy FDA review of Duchenne drug vamorolone
Pharmaphorum
Fri, 10/28/22 - 10:26 am
Santhera
Duchenne Muscular Dystrophy
vamorolone
FDA
FDA Keeps Jazz’s SCLC Treatment on the Market Despite Failed Confirmatory Trial
BioSpace
Thu, 10/27/22 - 08:14 pm
Jazz Pharmaceuticals
FDA
Zepzelca
small cell lung cancer
FDA Guidance Raises Concerns about Y-mAbs’ Neuroblastoma Treatment before Adcomm
BioSpace
Thu, 10/27/22 - 10:59 am
FDA
Y-mAbs Therapeutics
neuroblastoma
omburtamab
J&J nabs FDA okay for BCMA bispecific Tecvayli
Pharmaphorum
Wed, 10/26/22 - 07:00 pm
JNJ
Multiple Myeloma
Tecvayli
FDA

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