FDA

FDA puts Curis' leukemia trial on partial hold after patient death spurs review of muscle breakdown
Fierce Biotech
Mon, 04/4/22 - 10:35 am
Curis
FDA
clinical trials
patient deaths
emavusertib
acute myeloid leukemia
BMS Presents Robust Mavacamten Results in HCM Ahead of FDA Decision
BioSpace
Mon, 04/4/22 - 10:24 am
Bristol Myers Squibb
FDA
clinical trials
mavacamten
obstructive hypertrophic cardiomyopathy
FDA cuts off use of GSK's Covid treatment in almost half of the US as BA.2 spreads
Endpoints
Mon, 04/4/22 - 10:21 am
FDA
GSK
Vir Biotechnology
monoclonal antibodies
COVID-19
Omicron BA.2
Merck, amid pneumococcal vaccine race with Pfizer, suffers FDA delay for key pediatric use
Fierce Pharma
Fri, 04/1/22 - 10:45 am
Merck
Pfizer
vaccines
pneumococcal disease
Vaxneuvance
FDA
pediatric
Congress questions FDA, industry over MDUFA V delays
Medtech Dive
Fri, 04/1/22 - 10:36 am
Medtech
devices
FDA
regulatory
MDUFA
FDA says IT modernization came at right time for COVID
RAPS.org
Thu, 03/31/22 - 11:30 pm
FDA
process modernization
pandemic
COVID-19
Califf admits controversy over FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency
Stat
Thu, 03/31/22 - 11:22 pm
Robert Califf
FDA
Biogen
Aduhelm
An FDA panel reviewing Amylyx's ALS drug was moved by patient testimony—but they voted it down anyway
Fierce Biotech
Thu, 03/31/22 - 10:48 am
Amylyx
ALS
FDA
patients
AMX0035
After FDA hold, CytoDyn will appeal for pharma partnerships to save leronlimab
Fierce Biotech
Thu, 03/31/22 - 10:39 am
CytoDyn
FDA
clinical holds
HIV
leronlimab
CloudCath Wins FDA Nod for Connected Device that Brings Dialysis to the Home
Medical Devices and Diagnostics Industry
Thu, 03/31/22 - 10:30 am
devices
Medtech
CloudCath
FDA
connected devices
dialysis
FDA rejects Akebia drug, dealing another blow to anemia pills
BioPharma Dive
Thu, 03/31/22 - 10:24 am
Akebia Therapeutics
vadadustat
FDA
chronic kidney disease
anemia
Novo Nordisk snags high-dose Ozempic approval, turning up the heat on Lilly's Trulicity
Fierce Pharma
Wed, 03/30/22 - 11:11 am
Novo Nordisk
Ozempic
diabetes
FDA
Eli Lilly
Trulicity
Adagio knows its COVID-19 antibody works against old variants. Can it win EUA in the era of omicron?
Fierce Biotech
Wed, 03/30/22 - 10:55 am
Adagio Therapeutics
FDA
COVID-19
antibodies
ADG20
Amylyx faces an uphill battle
EP Vantage
Wed, 03/30/22 - 10:42 am
Amylyx
FDA
AMX0035
U.S. approves second Covid-19 booster for people 50 and older
Stat
Tue, 03/29/22 - 11:47 pm
Pfizer
BioNTech
Moderna Therapeutics
FDA
vaccines
boosters
COVID-19
ImmunoGen Ovarian Cancer Drug Reaches BLA Milestone
BioSpace
Tue, 03/29/22 - 11:37 pm
Immunogen
ovarian cancer
FDA
mirvetuximab soravtansine
The FDA endorses accelerated approval reforms
Stat
Tue, 03/29/22 - 11:34 pm
FDA
accelerated approvals
congress
Biden seeks $2.1B funding boost for FDA, part of pan-agency pandemic preparedness plan
Fierce Biotech
Mon, 03/28/22 - 07:52 pm
Joe Biden
FDA
funding
pandemic
Amylyx to answer for single-study ALS application at FDA advisory panel
Fierce Biotech
Mon, 03/28/22 - 07:46 pm
Amylyx
ALS
clinical trials
FDA
Data and regulatory roundup: Pfizer’s feat, an ADHD miss, Eli Lilly’s CRL & more
MedCity News
Mon, 03/28/22 - 10:17 am
FDA
Pfizer
etrasimod
Argenxy
efgartigimod
Aligos Therapeutics
Vallon Pharmaceuticals
Adderall
ORIC Pharmaceuticals
ORIC-101
Neurana Pharmaceuticals
tolperisone
Eli Lilly
sintilimab

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