FDA

Clearside’s wet AMD drug-device combo shines in Phase IIb study
Clinical Trials Arena
Fri, 10/11/24 - 09:40 am
Clearside Biomedical
clinical trials
wet age-related macular degeneration
CLS-AX
drug-device combos
FDA
Roche gets FDA green light for breast cancer drug Itovebi
Pharmaphorum
Fri, 10/11/24 - 09:34 am
Roche
FDA
Itovebi
metastatic breast cancer
FDA black box warning for antidepressants may have unintended consequences
Medical Marketing and Media
Wed, 10/9/24 - 09:18 pm
antidepressants
black box
suicide
FDA
Neuvivo files NDA seeking FDA approval for ALS treatment
Pharmaceutical Business Review
Tue, 10/8/24 - 10:15 am
Neuvivo
FDA
ALS
NP001
FDA places hold on Kezar Life Sciences’ trial for lupus nephritis treatment
Clinical Trials Arena
Mon, 10/7/24 - 11:29 am
Kezar Life Sciences
lupus nephritis
FDA
zetomipzomib
clinical trials
FDA grants priority review for AstraZeneca’s Calquence sNDA
Pharmaceutical Business Review
Fri, 10/4/24 - 09:26 am
AstraZeneca
Calquence
FDA
priority review
Thermo Fisher's plant making infant RSV drug breached FDA rules, documents show
Reuters
Fri, 10/4/24 - 09:22 am
Thermo Fisher
FDA
RSV
Beyfortus
Sanofi
AstraZeneca
drug manufacturing
BMS' Opdivo joins the perioperative lung cancer treatment ring with key FDA approval
Fierce Pharma
Thu, 10/3/24 - 10:25 pm
Bristol Myers Squibb
Opdivo
FDA
non-small cell lung cancer
Lilly's weight-loss drug removed from FDA's shortage list
Reuters
Thu, 10/3/24 - 10:06 am
Eli Lilly
FDA
drug shortages
Mounjaro
5 FDA decisions to watch in the fourth quarter
BioPharma Dive
Wed, 10/2/24 - 11:24 am
FDA
Bridge Bio
acoramidis
AstraZeneca
Daiichi Sankyo
Dato-DXd
Vertex Pharmaceuticals
Vanza Triple
PTC Therapeutics
Upstaza
Bristol Myers Squibb
Opdivo
With post hoc analysis, BridgeBio touts case for acoramidis as FDA decision date draws near
Fierce Biotech
Mon, 09/30/24 - 09:57 am
BridgeBio
acoramidis
FDA
transthyretin amyloid cardiomyopathy
AbbVie seeks FDA approval for non-small cell lung cancer treatment
Pharmaceutical Business Review
Mon, 09/30/24 - 09:45 am
AbbVie
FDA
Teliso-V
non-small cell lung cancer
After Sanofi's first-line myeloma nod, J&J strikes back with new tranche of Darzalex data
Fierce Pharma
Mon, 09/30/24 - 09:30 am
Sanofi
JNJ
Sarclisa
Darzalex Faspro
Multiple Myeloma
FDA
Bristol Myers Squibb wins FDA approval for first new schizophrenia drug in 30 years
Medical Marketing and Media
Mon, 09/30/24 - 09:28 am
Bristol Myers Squibb
FDA
schizophrenia
Cobenfy
FDA, after delay, clears Regeneron and Sanofi drug for COPD
BioPharma Dive
Mon, 09/30/24 - 09:25 am
Regeneron
Sanofi
Dupixent
COPD
FDA
Experts support FDA's plan for restrictions on PD-1 drugs in stomach, esophageal cancers
Fierce Pharma
Thu, 09/26/24 - 06:35 pm
FDA
regulatory
PD-1 inhibitors
stomach cancer
gastric cancer
esophageal cancer
FDA eyes first schizophrenia drug shift in decades
Axios
Thu, 09/26/24 - 11:02 am
Bristol Myers Squibb
FDA
KarXT
schizophrenia
AZ gets sought-after lung cancer approval for Tagrisso
Pharmaphorum
Thu, 09/26/24 - 10:59 am
AstraZeneca
Tagrisso
FDA
non-small cell lung cancer
FDA approves IntraBio's drug for rare genetic disease
Reuters
Tue, 09/24/24 - 10:00 pm
FDA
IntraBio
Niemann-Pick disease
Immunotherapy May Not Benefit All Gastroesophageal Cancer Patients, FDA Staff Says
MedPage Today
Tue, 09/24/24 - 09:54 pm
FDA
ODAC
gastroesophageal cancer
PD-L1

Pages