FDA

BMS builds case for mavacamten label ahead of FDA decision
Pharmaforum
Thu, 02/17/22 - 11:01 am
Bristol Myers Squibb
mavacamten
obtructive hypertrophic cardiomyopathy
MyoKardia
FDA
FDA says volume manufacturing deadline is not a requirement after drugmakers lash out
Endpoints
Thu, 02/17/22 - 10:51 am
FDA
drug manufacturing
regulatory
CARES Act
SwanBio gets FDA Fast Track designation for adrenomyeloneuropathy therapy
Pharmaceutical Business Review
Thu, 02/17/22 - 10:47 am
SwanBio Therapeutics
gene therapy
FDA
fast track
SBT101
AMN
Generic drug approvals continued to fall in 2021
RAPS.org
Wed, 02/16/22 - 11:13 pm
FDA
generics
Califf confirmed as FDA chief in close vote, ending protracted vacancy at health agency
BioPharma Dive
Tue, 02/15/22 - 11:40 pm
FDA
Senate
Robert Califf
Latest data on Bayer's Essure show more patients had device removed: FDA
Medtech Dive
Tue, 02/15/22 - 10:43 am
Bayer
Essure
devices
patients
contraceptives
Medtech
FDA
In a cliffhanger, Rob Califf clears first hurdle on path to Senate confirmation as next FDA commissioner
Endpoints
Tue, 02/15/22 - 10:22 am
FDA
Senate
Robert Califf
Joe Biden
Larimar kept in limbo as FDA maintains clinical hold on leading candidate
Fierce Biotech
Tue, 02/15/22 - 10:21 am
Larimar Therapeutics
Friedreich's Ataxia
FDA
clinical hold
CTI-1601
Legend's early-stage CAR-T on FDA hold after single patient dosed
Fierce Biotech
Tue, 02/15/22 - 10:15 am
Legend Biotech
CAR-T
FDA
clinical trials
clinical hold
LB1901
Senseonics’ long-lasting continuous glucose monitor receives FDA approval
MedCity News
Tue, 02/15/22 - 10:12 am
Senseonics
FDA
diabetes
devices
Medtech
continuous glucose monitoring
glucose monitors
Device group urges FDA to refine software function guidance
RAPS.org
Mon, 02/14/22 - 11:42 pm
devices
Medtech
software
FDA
Denali Receives Formal Letter Regarding FDA Hold On Alzheimer's Potential Program
Benzinga
Mon, 02/14/22 - 11:00 am
Denali Therapeutics
FDA
DNL919
clinical hold
Alzheimer's disease
Senate Finance chair asks Rob Califf for more details around potential accelerated approval reforms
Endpoints
Sat, 02/12/22 - 11:56 pm
FDA
Robert Califf
Senate
Cassava scores a win as FDA declines to intervene in petition to stop its Alzheimer's drug trials
Fierce Biotech
Fri, 02/11/22 - 11:41 am
Cassava Sciences
FDA
clinical trials
Alzheimer's disease
simufilam
After a contentious lead-up, Rob Califf likely to be confirmed as FDA commissioner next week
Endpoints
Thu, 02/10/22 - 08:05 pm
FDA
regulatory
Robert Califf
Joe Biden
Senate
FDA denies Ardelyx’s appeal against kidney drug rejection, hammering another nail in tenapanor’s coffin
Fierce Biotech
Thu, 02/10/22 - 10:30 am
Ardelyx
FDA
complete response letter
tenapanor
chronic kidney disease
A small Seattle biotech wants to take on GlaxoSmithKline's emerging Shingrix blockbuster. RA Capital is on board
Endpoints
Thu, 02/10/22 - 10:27 am
GSK
Shingrix
FDA
RA Capital
Curevo Vaccine
Eisai bites back against restricted coverage plan for Aduhelm
Pharmaforum
Thu, 02/10/22 - 10:16 am
Eisai
Biogen
Aduhelm
Alzheimer's disease
FDA
CMS
China-Developed Drugs for U.S. Market Could Face Steep Hill
BioSpace
Wed, 02/9/22 - 11:01 am
China
drug approvals
FDA
clinical trials
Premature birth drug saga drags on as Covis questions fairness of FDA hearing
Endpoints
Wed, 02/9/22 - 10:17 am
Makena
Covis Pharma
FDA
premature birth

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