FDA

Omnibus spending bill would give FDA a $102M boost for FY2022
RAPS.org
Wed, 03/9/22 - 11:11 pm
regulatory
legislation
FDA
FDA's oncology adcomm to review PI3K inhibitors in blood cancers in April
Endpoints
Wed, 03/9/22 - 10:59 am
FDA
regulatory
blood cancers
PI3k inhibitor
FDA accelerated approvals targeted for revamp in House Energy and Commerce committee chair's new bill
Fierce Pharma
Tue, 03/8/22 - 10:11 am
FDA
accelerated approvals
FDA offers funding for biosimilar regulatory science pilot
RAPS.org
Mon, 03/7/22 - 10:54 pm
regulatory
FDA
biosimilars
FDA hands Bristol Myers a landmark approval in early-stage lung cancer after just five days
Endpoints
Mon, 03/7/22 - 10:00 am
FDA
Bristol Myers Squibb
Opdivo
early-stage lung cancer
FDA regulatory roundup: two approvals, three rejections & one clinical hold
MedCity News
Sun, 03/6/22 - 11:08 pm
FDA
JNJ
CTI BioPharma
Gilead Sciences
Amryt Pharma
Reata Pharmaceuticals
BMS, Novartis, Akebia and more face FDA approval decisions soon, with big sales on the line
Fierce Pharma
Thu, 03/3/22 - 10:33 am
FDA
drug approvals
FibroGen
AstraZeneca
daprodustat
Bristol Myers Squibb
Opdivo
Roche
tiragolumab
Merck
favezelima
bInnovent
Eli Lilly
Akeso Biopharma
Sino Biopharmaceutical
Novartis
Ukoniq
TG Therapeutics
GW Pharmaceuticals
Marinus Pharmaceuticals
Cassava 10K Filing Warns of Anticipated Hold, Paints Dire Picture of Alzheimer's Space
BioSpace
Thu, 03/3/22 - 10:23 am
Cassava Sciences
FDA
clinical trials
Alzheimer's disease
simufilam
FDA slaps hold on Finch's C. diff med to get info on COVID-19 screening for donor-derived therapy
Fierce Biotech
Thu, 03/3/22 - 10:21 am
Finch Therapeutics
C. difficile
clinical hold
FDA
clinical trials
microbiome
FDA begins court-mandated release of thousands of pages on Pfizer's Covid-19 vaccine review
Endpoints
Wed, 03/2/22 - 10:15 pm
FDA
Pfizer
vaccines
COVID-19
Pfizer revs up to leave GSK in the dust as maternal RSV vax granted FDA breakthrough tag
Fierce Biotech
Wed, 03/2/22 - 12:16 pm
Pfizer
GSK
vaccines
RSV
PF-06482077
FDA
breakthrough status
FDA sets back Karyopharm's bid to broaden use of cancer drug
BioPharma Dive
Wed, 03/2/22 - 12:08 pm
Karyopharm Therapeutics
Selinexor
clinical trials
FDA
cancer
FDA quickly follows a voluntary pause for CAR-T 2.0 with a clinical hold to investigate 2 patient deaths
Endpoints
Wed, 03/2/22 - 10:28 am
Celyad
FDA
patient deaths
CAR-T
clinical holds
FDA rejects Gilead's closely watched HIV drug
BioPharma Dive
Tue, 03/1/22 - 10:05 pm
Gilead Sciences
HIV
FDA
lenacapavir
A new JAK inhibitor earns FDA nod in myelofibrosis, setting up a fight with Incyte, Bristol Myers
Endpoints
Tue, 03/1/22 - 10:35 am
CTI BioPharma
JAK inhibitors
Vonjo
pacritinib
FDA
myelofibrosis
Incyte
Bristol Myers Squibb
AbbVie files sNDA to FDA for chronic graft versus host disease therapy
Pharmaceutical Business Review
Tue, 03/1/22 - 10:24 am
AbbVie
Imbruvica
graft vs host disease
FDA
J&J, Legend cell therapy approved by FDA for multiple myeloma
BioPharma Dive
Mon, 02/28/22 - 11:44 pm
JNJ
Legend Biotech
FDA
Multiple Myeloma
Carvykti
CAR-T
Bristol Myers' Opdivo steps in FDA fast lane for potential first-in-class nod in pre-surgery lung cancer
Fierce Pharma
Mon, 02/28/22 - 11:32 am
Bristol Myers Squibb
FDA
Opdivo
priority review
non-small cell lung cancer
Amryt Pharma Shares Tumble After FDA Rejects Oleogel-S10 Application
Marketwatch
Mon, 02/28/22 - 11:29 am
Amryt Pharma
FDA
Oleogel-S10
epidermolysis bullosa
FDA rejects Reata Pharma chronic kidney disease drug; new trial needed
MedCity News
Mon, 02/28/22 - 09:15 am
Reata Pharmaceuticals
Bardoxolone
Alport syndrome
kidney disease
FDA

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