FDA

Geron's blood disorder drug gets FDA advisers' backing
Reuters
Thu, 03/14/24 - 06:26 pm
Geron
FDA
imetelstat
FDA approves expanded use of Mirum's liver disease drug
Reuters
Wed, 03/13/24 - 10:40 pm
Mirum Pharmaceuticals
FDA
liver disease
PFIC
FDA staff raises concerns over data from J&J, Bristol's CAR-T therapies
Reuters
Wed, 03/13/24 - 10:46 am
FDA
JNJ
Bristol Myers Squibb
blood cancers
cell therapy
Geron faces uphill battle at FDA meeting as agency questions benefit-risk profile of imetelstat
Fierce Biotech
Wed, 03/13/24 - 10:37 am
Geron
FDA
imetelstat
blood cancers
FDA guidelines consider amyloid reduction 'reasonably likely' to predict Alzheimer's benefit
Fierce Biotech
Tue, 03/12/24 - 11:34 am
Biogen
Eisai
Aduhelm
FDA
Alzheimer's disease
amyloid
Eli Lilly
donanemab
Johnson & Johnson files sBLA for ulcerative colitis treatment
Pharmaceutical Business Review
Tue, 03/12/24 - 11:19 am
JNJ
FDA
Tremfya
ulcerative colitis
FDA staff raises concerns on Geron's blood disorder drug
Reuters
Tue, 03/12/24 - 11:06 am
Geron
FDA
imetelstat
myelodysplastic syndrome
Lilly's lebrikizumab, delayed at FDA, clears eczema in people with skin of color
Fierce Biotech
Mon, 03/11/24 - 05:11 pm
Eli Lilly
eczema
lebrikizumab
FDA
Biden Administration Requests $7.13Bn FDA Budget For FY2025, Includes $3.3Bn In User Fees
Medtech Insight
Mon, 03/11/24 - 05:02 pm
FDA
user fees
Neuralink's Animal Experiments Under FDA Fire
Medical Devices and Diagnostics Industry
Mon, 03/11/24 - 05:00 pm
Neuralink
Elon Musk
FDA
animal research
FDA Adcomm to Tackle Complexity of CAR-T for Multiple Myeloma
BioSpace
Mon, 03/11/24 - 11:53 am
CAR-T
Multiple Myeloma
FDA
Bristol Myers Squibb
2seventy bio
Abecma
JNJ
Legend Biotech
Carvykti
Viatris' launch plans scuttled as FDA rebuffs long-acting MS drug from partner Mapi
Fierce Pharma
Mon, 03/11/24 - 11:32 am
Viatris
FDA
Mapi Pharma
MS
multiple sclerosis
glatiramer acetate depot
FDA clears use of Novo’s obesity drug to protect heart health
BioPharma Dive
Sun, 03/10/24 - 08:43 pm
Novo Nordisk
FDA
Wegovy
Fresenius Kabi’s Biosimilar for Actemra Gets FDA Approval
BioSpace
Sun, 03/10/24 - 08:25 pm
Fresenius Kabi
FDA
biosimilars
Actemra
Tyenne
Genentech
Lilly’s Donanemab Hit with Surprise Delay, Set to Face FDA Adcomm
BioSpace
Fri, 03/8/24 - 11:55 am
Eli Lilly
FDA
Alzheimer's disease
donanemab
Bristol Myers, overshadowed by ADC rival, wins FDA nod for Opdivo combo in bladder cancer
Fierce Pharma
Fri, 03/8/24 - 11:54 am
Bristol Myers Squibb
Opdivo
FDA
bladder cancer
MindMed gets FDA breakthrough tag for LSD in anxiety
Pharmaphorum
Fri, 03/8/24 - 11:03 am
MindMed
FDA
LSD
anxiety
MM120
FDA approves expanded use of BeiGene's blood cancer drug
Reuters
Thu, 03/7/24 - 05:30 pm
BeiGene
FDA
Brukinsa
Gazyva
PhotonPharma receives FDA clearance for ovarian cancer vaccine trial
Clinical Trials Arena
Wed, 03/6/24 - 11:42 am
Photon Pharma
FDA
clinical trials
Innocell
vaccines
ovarian cancer
Sandoz Nabs FDA Approvals for First Two Biosimilars for Amgen’s Denosumab
BioSpace
Wed, 03/6/24 - 11:29 am
Sandoz
biosimilars
FDA
Amgen
denosumab
Prolia
Jubbonti
Xgeva
Wyost

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