Browsing Tag
U.S. Food and Drug Administration
102 posts
Why Teva’s once-monthly olanzapine shot could finally change how schizophrenia is treated in the U.S.
Find out how Teva’s FDA-accepted once-monthly olanzapine injection could reshape schizophrenia care and what investors and clinicians will watch next.
Will intravenous oncolytic viruses finally overcome metastatic delivery barriers?
ViroMissile, Inc. expands IDOV-Immune into U.S. cancer centers after FDA IND clearance. Explore what this means for systemic viral oncology.
NATCO Pharma (NSE: NATCOPHARM) wins CDSCO approval for semaglutide as FDA compliance risks recede at its API unit
NATCO Pharma Limited secures CDSCO approval for semaglutide as U.S. FDA risks ease. Find out what this means for growth, execution, and investors.
Orphan drug designation for CTD402 raises stakes for allogeneic CAR-T in relapsed T-cell leukemia
CTD402 secures FDA orphan designation. Read how this raises execution stakes for allogeneic CAR-T in relapsed T-cell leukemia.
Stargardt disease pipeline shifts as Belite Bio clears enrollment risk for tinlarebant
Discover why Belite Bio’s DRAGON II enrollment milestone shifts Stargardt disease drug development and what it means for investors and regulators.
GRAIL (Nasdaq: GRAL) files FDA application for Galleri test, aiming to redefine how cancer is detected in asymptomatic patients
GRAIL files FDA approval for Galleri, its blood-based test for early cancer detection. Find out what it means for diagnostics, payers, and public health.
Keysight Technologies (NYSE: KEYS) launches wireless coexistence test platform for FDA-compliant devices
Keysight launches an automated RF coexistence test platform to help engineers meet ANSI C63.27 and FDA guidance. Find out what it means for the sector.
J&J’s CAPLYTA nearly doubles remission rates in Phase 3 MDD trial
Find out how Johnson & Johnson’s CAPLYTA is redefining remission in depression with six-month data that could reshape MDD treatment benchmarks.
Medtronic invests in Anteris (ASX: AVR) to fund DurAVR trial and TAVR platform expansion
Anteris Technologies has raised USD 320M, including USD 90M from Medtronic, to fund its global DurAVR heart valve trial. Read what this means for TAVR competition.
Eli Lilly’s sofetabart mipitecan earns FDA Breakthrough Therapy status in platinum-resistant ovarian cancer
Eli Lilly's sofetabart mipitecan receives FDA Breakthrough Therapy designation in platinum-resistant ovarian cancer. Find out what this means for the ADC space.