FDA

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
Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.
BioPharma Dive
Thu, 05/8/25 - 11:11 am
FDA
CBER
Vinay Prasad
FDA ends advance notice for foreign drugmaker inspections
Beckers Hospital Review
Thu, 05/8/25 - 11:02 am
FDA
regulatory
foreign drug inspections
drug manufacturing
The math of biotech VC is about to change
Axios
Thu, 05/8/25 - 10:55 am
FDA
Vinay Prasad
biotech
venture capital
US judge sides with FDA's removal of Lilly's weight loss drug from shortage list
MSN/Reuters
Wed, 05/7/25 - 11:05 pm
FDA
Eli Lilly
Zepbound
Mounjaro
drug shortages
FDA set to meet this month on COVID vaccines
BioPharma Dive
Wed, 05/7/25 - 10:54 pm
FDA
adcomm
vaccines
COVID-19

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