Browsing Tag
U.S. Food and Drug Administration
105 posts
SCY-247 intravenous trial signals strategic shift in SCYNEXIS, Inc.’s antifungal pipeline
SCYNEXIS, Inc. advances IV SCY-247 into Phase 1. Discover what this signals for antifungal resistance and hospital markets.
Neurizon Therapeutics (ASX: NUZ) just crossed the threshold every ALS biotech dreams about. Now the hard part starts.
Neurizon Therapeutics (ASX: NUZ) doses first ALS patient in the HEALEY Platform Trial. What the Phase 2/3 design means for investors and the sector. Read more.
FDA clears Bysanti and suddenly Vanda Pharmaceuticals Inc has no margin for execution failure
FDA approval of Bysanti sends Vanda Pharmaceuticals Inc stock higher. Read why execution now matters more than hype in schizophrenia and bipolar markets.
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.