FDA

AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race
Fierce Pharma
Sun, 05/21/23 - 07:46 pm
AbbVie
Genmab
FDA
anti-CD20
epcoritamab
diffuse large B-cell lymphoma
Epkinly
Galera earns key FDA designation for pancreatic cancer drug
Clinical Trials Arena
Fri, 05/19/23 - 11:29 am
Galera Therapeutics
pancreatic cancer
FDA
rucosopasem
orphan drugs
FDA Approves Bausch + Lomb, Novaliq Dry Eye Disease Drug
BioSpace
Fri, 05/19/23 - 10:23 am
Bausch + Lomb
Novaliq
Miebo
FDA
dry eye disease
New FDA Guidance Aims to Increase Number of Children in Clinical Trials
BioSpace
Fri, 05/19/23 - 10:11 am
FDA
pediatric
clinical trials
FDA advisory panel backs Pfizer’s RSV vaccine, but expresses some safety concerns
Stat
Thu, 05/18/23 - 08:45 pm
Pfizer
RSV
vaccines
FDA
AbbVie's Rinvoq scores its 7th FDA nod, this one for Crohn's disease
Fierce Pharma
Thu, 05/18/23 - 08:36 pm
AbbVie
FDA
Rinvoq
Crohn's Disease
Humira
FDA Shows Confidence in Pfizer’s Maternal RSV Shot Ahead of Panel
BioSpace
Thu, 05/18/23 - 11:12 am
Pfizer
FDA
RSV
vaccines
Abrysvo
FDA staff unsure NASH drug’s ‘modest’ benefits outweigh safety risks
BioPharma Dive
Wed, 05/17/23 - 10:57 pm
FDA
NASH
OCA
obeticholic acid
Intercept Pharma
Investigation raises questions over lack of 'substantial evidence' for FDA approved antibiotic
Medical Xpress
Wed, 05/17/23 - 10:53 pm
Merck
antibiotics
Recarbrio
FDA
BMJ
Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market
Medtech Dive
Wed, 05/17/23 - 10:45 pm
Abbott Labs
Medtech
FDA
Spinal Cord Stimulation
back pain
BurstDR
Nevro
Allergan's new skin-smoothing product gets FDA nod—with novel delivery mechanism
Fierce Pharma
Wed, 05/17/23 - 10:40 pm
AbbVie
FDA
Skinvive
Juvederm
aesthetics
Pfizer RSV vaccine seen as effective against severe disease, FDA documents say
Stat
Tue, 05/16/23 - 10:33 pm
Pfizer
RSV
vaccines
infants
pregnancy
FDA
Byondis' breast cancer drug fails to bloom as FDA denies approval
Fierce Biotech
Tue, 05/16/23 - 10:27 pm
Byondis
antibody-drug conjugate
FDA
breast cancer
HER-2 positive breast cancer
DiaMedica prepares to end 10-month FDA hold on late-phase stroke trial by halving dose
Fierce Biotech
Tue, 05/16/23 - 12:49 pm
DiaMedica Therapeutics
FDA
clinical trials
stroke
FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy
Fierce Biotech
Mon, 05/15/23 - 11:18 am
Sarepta Therapeutics
FDA
DMD
gene therapy
Duchenne Muscular Dystrophy
SiSaf gets green light from FDA for osteopetrosis treatment
Biopharma Reporter
Mon, 05/15/23 - 10:16 am
SiSaf
orphan drugs
pediatric
FDA
osteopetrosis
SIS-101-ADO
Astellas' Menopause Drug Scores FDA Approval, After Regulatory Setback
Yahoo/Benzinga
Mon, 05/15/23 - 11:21 am
Astellas
FDA
hot flashes
Veozah
fezolinetant
The waxing and waning of the speedy approval
EP Vantage
Mon, 05/15/23 - 09:58 am
FDA
drug approvals
accelerated approvals
AbbVie
AstraZeneca
Bayer
Bristol Myers Squibb
JNJ
Merck
Merck KGaA
Novartis
Pfizer
First epinephrine nasal spray clears key FDA hurdle, promising needle-free alternative
CBS News
Thu, 05/11/23 - 08:57 pm
ARS Pharmaceuticals
FDA
epinephrine nasal spray
Neffy
Japan's Otsuka Pharma-Lundbeck Partnered Depression Drug Gets FDA Approval For Alzheimer's Agitation
Yahoo/Benzinga
Thu, 05/11/23 - 08:53 pm
Otsuka
Lundbeck
FDA
Rexulti
Alzheimer's agitation

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