FDA

FDA declines to approve Merck-Daiichi's 'guided missile' cancer drug
Reuters
Thu, 06/27/24 - 11:18 am
Merck
Daiichi Sankyo
cancer
FDA
patritumab deruxtecan
antibody-drug conjugate
FDA reveals diversity action plan guide for clinical trials
Pharmaphorum
Thu, 06/27/24 - 11:14 am
clinical trials
FDA
regulatory
diversity
After 33 years, Geron’s first approval marks a turn in Nobel-winning science
Pharma Voice
Wed, 06/26/24 - 09:57 am
Geron
Rytelo
imetelstat
FDA
Nobel Prize
FDA Again Hits AbbVie Parkinson’s Treatment With Complete Response Letter
BioSpace
Tue, 06/25/24 - 11:29 am
AbbVie
Parkinson's Disease
FDA
ABBV-951
5 FDA Decisions to Watch in the Second Half of 2024
BioSpace
Mon, 06/24/24 - 11:29 am
FDA
Eli Lilly
donanemab
Alzheimer's disease
Adaptimmune
afami-cel
advanced synovial sarcoma
Lykos Therapeutics
MDMA
PTSD
Bristol Myers Squibb
KarXT
schizophrenia
Daiichi Sankyo
AstraZeneca
Dato-DXd
non-small cell lung cancer
BMS gets FDA approval for Krazati in colorectal cancer
Pharmaphorum
Mon, 06/24/24 - 10:50 am
Bristol Myers Squibb
FDA
Krazati
colorectal cancer
What Would a Donanemab Approval Mean for Leqembi?
BioSpace
Mon, 06/24/24 - 10:47 am
Eli Lilly
donanemab
Biogen
Eisai
Leqembi
FDA
Alzheimer's disease
Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes
Stock Titan
Fri, 06/21/24 - 11:15 am
Lexicon Pharmaceuticals
type 1 diabetes
FDA
sotagliflozin
Sarepta Duchenne gene therapy wins broader use from FDA
BioPharma Dive
Thu, 06/20/24 - 06:09 pm
Sarepta Therapeutics
gene therapy
FDA
DMD
Elevidys
FDA approves Biotests’s plasma-derived treatment for immunodeficiencies
Biopharma Reporter
Thu, 06/20/24 - 11:33 am
Biotest
FDA
Yummugo
PID
FDA places partial clinical hold on Zentalis’ trials of azenosertib for cancer
Clinical Trials Arena
Thu, 06/20/24 - 11:24 am
Zentalis Pharmaceuticals
azenosertib
clinical trials
FDA
FDA approves Abbvie's Skyrizi for ulcerative colitis
PR Newswire
Tue, 06/18/24 - 07:56 pm
AbbVie
FDA
Skyrizi
ulcerative colitis
Merck's Keytruda snags 40th US indication, leaps ahead of GSK with broad endometrial cancer approval
Fierce Pharma
Tue, 06/18/24 - 11:40 am
Merck
Keytruda
endometrial cancer
GSK
FDA
KalVista files first oral on-demand HAE drug with FDA
Pharmaphorum
Tue, 06/18/24 - 11:23 am
KalVista
HAE
sebetralstat
FDA
Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults
Fierce Pharma
Mon, 06/17/24 - 10:37 pm
Merck
vaccines
FDA
pneumococcal disease
Capvaxive
V116
Xeltis sets crosshairs on US pivotal trial for aXess after IDE green light
Clinical Trials Arena
Mon, 06/17/24 - 10:35 pm
Xeltis
aXess
FDA
clinical trials
Amgen’s Blincyto approved by FDA for new acute lymphoblastic leukaemia indication
PM Live
Mon, 06/17/24 - 10:28 pm
Amgen
FDA
Blincyto
acute lymphoblastic leukemia
FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'
Fierce Biotech
Mon, 06/17/24 - 11:48 am
FDA
MediLink Therapeutics
BioNTech
clinical trials
antibody-drug conjugates
AstraZeneca Imfinzi plus chemotherapy gets US nod for certain type of endometrial cancer
Reuters
Mon, 06/17/24 - 11:31 am
AstraZeneca
Imfinzi
endometrial cancer
FDA
FDA asks COVID vaccine makers to target KP.2 strain, if feasible, for next shot
Reuters
Sun, 06/16/24 - 08:55 pm
FDA
COVID-19
vaccines

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