U.S. Food and Drug Administration (FDA) Accepts Tevas New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults
Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the…
FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens
SANTA MARIA, Calif. and GUIPRY, France, Feb. 18, 2026 /PRNewswire/ -- In a…
FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX, Expanding Clinical Microbiology Capabilities
MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that…
Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470
Press Release Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA…
LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System
Ultra-fast point-of-care molecular diagnostics platform for key respiratory pathogens delivers results in…
Novel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF
SHANGHAI, Feb. 12, 2026 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio")…
AB Science announced that the Food and Drug Administration (FDA) granted the status of Minor Use in Major Species (MUMS) for Masivet in the treatment of canine mast cell tumors
PRESS RELEASE AB SCIENCE ANNOUNCES THAT THE FDA HAS GRANTED THE STATUS…
Hemex Health Receives FDA Breakthrough Device Designation for Gazelle Hb Variant Test
PORTLAND, Ore., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Hemex Health, a medical…
Pharming Group receives Complete Response Letter from U.S. FDA for sNDA for Joenja (leniolisib) in children aged 4 to 11 years with APDS
Leiden, the Netherlands, February 1, 2026: Pharming Group (Euronext: PHARM; Nasdaq: PHAR)…
QTX-2101 Awarded FDA Fast Track Designation for the Treatment of Acute Promyelocytic Leukemia
CHICAGO, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Quetzal Therapeutics, a biopharmaceutical company…
