FDA

FDA clears its first blood test for diagnosing Alzheimer's disease, with Fujirebio's Lumipulse
Fierce Biotech
Sun, 05/18/25 - 10:38 pm
Fujirebio Diagnostics
FDA
Alzheimer's disease
diagnostics
Lumipulse G
Weighing approval bids from J&J, Pfizer and Roche, FDA scrutinizes data ahead of adcomm
Fierce Pharma
Sun, 05/18/25 - 10:33 pm
FDA
JNJ
Pfizer
Roche
cancer
accomm
FDA Clears Novavax, Inc. (NVAX)’s COVID-19 Vaccine with Usage Restrictions
Yahoo Finance
Sun, 05/18/25 - 10:26 pm
Novavax
vaccines
COVID-19
FDA
Incyte's PD-1 drug brings immunotherapy to anal cancer
Pharmaphorum
Fri, 05/16/25 - 11:16 am
Incyte
Zynyz
anal cancer
FDA
After FDA Cuts, Planning for Upcoming ODAC Meeting Has Been ‘Absolute Chaos’
BioSpace
Thu, 05/15/25 - 10:48 pm
FDA
ODAC
layoffs
FDA approves Amneal's self-administered migraine treatment
MSN/Reuters
Thu, 05/15/25 - 11:23 am
Amneal Pharmaceuticals
migraines
Brekiya
FDA
autoinjectors
FDA delays decision on Biohaven's rare disease drug filing, plans adcomm
Fierce Biotech
Thu, 05/15/25 - 11:02 am
Biohaven
FDA
troriluzole
adcomm
Rare Diseases
AbbVie advances solid tumor agenda with FDA nod for lung cancer ADC Emrelis
Fierce Pharma
Wed, 05/14/25 - 10:50 pm
AbbVie
solid tumors
FDA
Emrelis
advanced non-squamous non-small cell lung cancer
Former FDA head Robert Califf says RFK Jr.’s vaccine rhetoric is ‘doing harm’ to Americans
Stat
Wed, 05/14/25 - 11:02 pm
Robert Califf
HHS
Robert F Kennedy Jr.
FDA
vaccines
FDA moves to ban fluoride supplements for kids, removing a key tool for dentists
NPR
Wed, 05/14/25 - 11:18 am
FDA
fluoride
HHS
Robert F Kennedy Jr.
dental health
FDA accepts Regenxbio’s application for MPS II gene therapy
World Pharmaceuticals Frontiers
Wed, 05/14/25 - 11:15 am
Regenxbio
FDA
RGX-121
Hunter Syndrome
gene therapy
FDA's plan to roll out AI agencywide raises questions
Axios
Tue, 05/13/25 - 11:04 am
FDA
artificial intelligence
genAI
FDA, CDC call for pause of chikungunya shot rollout in older adults
Fierce Pharma
Mon, 05/12/25 - 12:02 pm
FDA
CDC
chikungunya virus
vaccines
Valneva
Zevaskyn Gets FDA Nod as First Cell Therapy for Rare, Debilitating Skin Disease
Xtalks
Sun, 05/11/25 - 10:02 pm
Abeona Therapeutics
zamikeracel
pz-cel
FDA
Zevaskyn
rare disease
The FDA approves first U.S. at-home tool as a Pap-smear alternative
NPR
Sun, 05/11/25 - 09:59 pm
FDA
cervical cancer
Teal Health
Medtech
pap smears
FDA chief Martin Makary sets June deadline for genAI rollout
Clinical Trials Arena
Fri, 05/9/25 - 09:41 am
FDA
Marty Makary
artificial intelligence
genAI
FDA layoffs could slow safety communications, experts warn
BioPharma Dive
Fri, 05/9/25 - 09:39 am
FDA
regulatory
drug safety
layoffs
recalls
FDA misses another approval decision target date, this time for GSK's Nucala in COPD
Fierce Pharma
Fri, 05/9/25 - 09:36 am
FDA
HHS
GSK
COPD
Nucala
regulatory
drug approvals
In first oncology expert meeting under Makary, FDA spotlights cancer drugs from J&J, Pfizer, Roche and UroGen
Fierce Pharma
Thu, 05/8/25 - 10:56 pm
FDA
Richard Pazdur
Marty Makary
cancer
oncology
JNJ
Pfizer
Roche
Urogen
Accelerated FDA Approval Makes Verastem Drug the First Therapy for Rare Type of Ovarian Cancer
MedCity News
Thu, 05/8/25 - 10:54 pm
Verastem Oncology
ovarian cancer
KRAS mutation
FDA

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