FDA

Bristol Myers Squibb's Opdivo reign expands with new earlier-stage melanoma nod
Fierce Pharma
Mon, 10/16/23 - 11:45 am
Bristol Myers Squibb
Opdivo
melanoma
FDA
AZ’s Tagrisso plus chemo get fast FDA review for lung cancer
Pharmaphorum
Mon, 10/16/23 - 10:20 am
AstraZeneca
FDA
Tagrisso
non-small cell lung cancer
EGFR-positive non-small cell lung cancer
Potential FDA approval for Supernus’s SPN-830 in Parkinson’s but challenges remain
Clinical Trials Arena
Mon, 10/16/23 - 10:18 am
Supernus
SPN-830
Parkinson's Disease
FDA
Pfizer takes aim at BMS' first-in-class Zeposia with FDA nod for ulcerative colitis drug Velsipity
Fierce Pharma
Fri, 10/13/23 - 10:35 am
Bristol Myers Squibb
Zeposia
Pfizer
Velsipity
etrasimod
ulcerative colitis
FDA
Alnylam CEO, ‘disappointed’ with FDA’s Onpattro rejection, pivots to the future
Pharma Voice
Thu, 10/12/23 - 05:32 pm
Alnylam
Pharma CEOs
Yvonne Greenstreet
FDA
Onpattro
Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial
BioSpace
Thu, 10/12/23 - 05:22 pm
Eli Lilly
mirikizumab
Crohn's Disease
FDA
PepGen cleared by FDA to begin study of muscular dystrophy drug
BioPharma Dive
Thu, 10/12/23 - 05:20 pm
PepGen
FDA
myotonic muscular dystrophy
FDA finds no misconduct at trial sites for Pfizer's Lyme disease shot, Care Access says
Reuters
Thu, 10/12/23 - 11:36 am
Pfizer
clinical trials
Lyme disease
Valneva
vaccines
FDA
Pfizer, playing catch-up with Novartis, bags FDA approval for drug combo in lung cancer
Fierce Pharma
Thu, 10/12/23 - 11:34 am
Pfizer
Braftovi
Maktovi
metastatic non-small cell lung cancer
FDA
FDA Rejects Alvotech’s Stelara Biosimilar as Manufacturing Problems Continue
BioSpace
Thu, 10/12/23 - 10:22 am
Alvotech
AVT04
JNJ
Stelara
biosimilars
FDA
FDA clears Kyverna’s IND for scleroderma therapy
Pharmaceutical Business Review
Thu, 10/12/23 - 10:06 am
Kyverna Therapeutics
KYV-101
scleroderma
FDA
FDA Decision On Interchangeable Exclusivity Allows Pfizer To Rival Boehringer On Adalimumab
Generics Bulletin
Mon, 10/9/23 - 11:35 pm
Pfizer
Humira
biosimilars
adalimumab
AbbVie
interchangeability
FDA
FDA denies expanded approval for Alnylam RNA drug
BioPharma Dive
Mon, 10/9/23 - 10:15 am
Alnylam
FDA
RNA
Patisiran
ATTR amyloidosis
Novartis Wins FDA Approval for Intravenous Cosentyx Formulation
BioSpace
Mon, 10/9/23 - 10:14 am
Novartis
Cosentyx
FDA
ankylosing spondylitis
psoriatic arthritis
non-radiographic axial spondyloarthritis
Amgen's Lumakras flunks FDA expert meeting, but market withdrawal looks unlikely for now
Fierce Pharma
Thu, 10/5/23 - 09:13 pm
Amgen
Lumakras
FDA
KRAS inhibitors
FDA expert panel endorses idea of removing a component from flu vaccine
Stat
Thu, 10/5/23 - 09:05 pm
FDA
vaccines
flu vaccines
FDA Puts Innate’s Lymphoma Trials on Partial Hold After Patient Death
BioSpace
Thu, 10/5/23 - 11:45 am
Innate Pharma
FDA
lymphoma
patient death
lacutamab
FDA adcomm backs US WorldMeds’ potential high-risk pediatric neuroblastoma drug
Medical Marketing and Media
Thu, 10/5/23 - 11:33 am
US WorldMeds
FDA
pediatric neuroblastoma
clinical trials
eflornithine
FDA calls for treatments for meth and cocaine addiction
Stat
Wed, 10/4/23 - 11:25 pm
FDA
drug development
addiction
cocaine addiction
meth addiction
FDA Says ‘Systemic Bias’ in Amgen’s Lumakras Trial Ahead of Adcomm Meeting
BioSpace
Wed, 10/4/23 - 11:08 am
Amgen
Lumakras
non-small cell lung cancer
FDA

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