FDA

Merck outflanks Pfizer's 20-valent shot with pneumococcal vaccine approval for kids
Endpoints
Wed, 06/22/22 - 10:57 am
Merck
FDA
vaccines
pneumococcal disease
Vaxneuvance
Pfizer
VBI Vaccines gets orphan drug designation for glioblastoma therapy
Pharmaceutical Business Review
Wed, 06/22/22 - 10:55 am
VBI Vaccines
FDA
VBI-1901
glioblastoma
brain cancer
vaccines
AbbVie files Qulipta for chronic migraine prevention
Pharmaforum
Wed, 06/22/22 - 10:21 am
AbbVie
Qulipta
migraines
FDA
BIO research outlines risks in changing accelerated approval pathway
Biopharma Reporter
Tue, 06/21/22 - 12:04 pm
BIO Conference
FDA
drug approvals
accelerated approvals
Rare disease outfit Acer fumbles at FDA, receiving CRL due to lack of inspection readiness at packaging manufacturer
Endpoints
Tue, 06/21/22 - 11:02 am
Acer Therapeutics
ACER-001
urea cycle disorders
FDA
complete response letter
PTC Ready to Take Another Shot at FDA Approval of DMD Drug
BioSpace
Tue, 06/21/22 - 10:58 am
PTC Therapeutics
Translarna
FDA
Duchenne Muscular Dystrophy
SoniVie receives FDA approval for Pilot study to treat Hypertension with Renal Artery Denervation TIVUS technology
Drugs.com
Mon, 06/20/22 - 10:47 am
SoniVie
hypertension
FDA
devices
Medtech
TIVUS
Acadia's Alzheimer’s Drug Voted Down by FDA Advisory Committee
BioSpace
Mon, 06/20/22 - 10:30 am
Acadia Pharmaceuticals
Nuplazid
FDA
Alzheimer's disease
Pushing for top spot in Big Pharma, AbbVie lands a key approval for its blockbuster Skyrizi
Endpoints
Mon, 06/20/22 - 10:33 am
AbbVie
Skyrizi
FDA
Crohn’s disease
FDA authorizes Pfizer and Moderna Covid vaccines for infants, toddlers, and preschoolers
Stat
Fri, 06/17/22 - 10:40 am
Moderna Therapeutics
Pfizer
BioNTech
vaccines
COVID-19
FDA
pediatric
Rhythm's Imcivree Scores FDA Approval in Bardet-Biedl Syndrome
BioSpace
Fri, 06/17/22 - 10:29 am
Rhythm Pharmaceuticals
Imcivree
Bardet-Biedl syndrome
FDA
With Positive Data, Checkpoint Looks to Add Second Indication to BLA
BioSpace
Thu, 06/16/22 - 11:11 pm
Checkpoint Therapeutics
FDA
cosibelimab
checkpoint inhibitors
ImmunityBio’s Patrick Soon-Shiong Discusses Quest to Orchestrate NK and T Cells
BioSpace
Thu, 06/16/22 - 10:21 am
ImmunityBio
Pantrick Soon-Shiong
bladder cancer
FDA
N-803
FDA advisory panel votes unanimously that Pfizer and Moderna shots be authorized for young children
Stat
Wed, 06/15/22 - 07:25 pm
FDA
COVID-19
vaccines
Pfizer
Moderna Therapeutics
pediatric
Covis' controversial Makena gets FDA hearing date in bid to stay on the market
Fierce Pharma
Wed, 06/15/22 - 07:16 pm
Makena
Covis Pharma
FDA
preterm birth
House subcommittee moves FDA $3.6B budget forward
RAPS.org
Wed, 06/15/22 - 07:12 pm
FDA
FDA panel weighs COVID vaccines for children as young as 6 months
Yahoo/Reuters
Wed, 06/15/22 - 11:05 am
COVID-19
vaccines
pediatric
FDA
Pfizer
Moderna Therapeutics
Senate HELP sends user fee reauthorization bill to floor vote
RAPS.org
Wed, 06/15/22 - 10:30 am
Senate
user fees
FDA
regulatory
FDA panel unanimously backs Moderna’s Covid vaccine for children ages 6 to 17
Stat
Tue, 06/14/22 - 09:03 pm
Moderna Therapeutics
FDA
COVID-19
vaccines
pediatric
180 Life Sciences Provides Update on Correspondence Received from U.K. and U.S. Regulatory Authorities on Pathway for a Therapy That Could Prevent Progression of Early-Stage Dupuytren’s Disease
BioSpace
Tue, 06/14/22 - 09:00 pm
180 Life Sciencs
FDA
MHRA
Dupuytren's Contracture
Dupuytren's disease
adalimumab

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