Browsing Tag
US Food and Drug Administration
333 posts
FDA accepts Airway’s IND for AT-100 for bronchopulmonary dysplasia treatment in preterm infants
Bronchopulmonary dysplasia treatment : Airway Therapeutics said that the US Food and Drug Administration (FDA) has accepted its…
Anixa Biosciences files IND with FDA for ovarian cancer CAR-T therapy
Anixa Biosciences said that it has filed an investigational new drug (IND) application for its ovarian cancer CAR-T…
Precigen gets FDA orphan drug status for PRGN-2012 in RRP
Precigen has secured orphan drug designation (ODD) for PRGN-2012 from the US Food and Drug Administration (FDA) in…
Cytocom gets FDA nod for phase 2 trial of Covid drug candidate CYTO-205
Cytocom has secured clearance from the US Food and Drug Administration (FDA) to undertake a phase 2 clinical…
J&J Ad26.COV2.S COVID-19 vaccine gets FDA emergency use authorization
Johnson & Johnson (J&J) said that the US Food and Drug Administration (FDA) has given emergency use authorization…
FDA approves G1 Therapeutics’ Cosela for reducing chemotherapy-induced bone marrow suppression
G1 Therapeutics has achieved a significant milestone with the recent U.S. Food and Drug Administration (FDA) approval of…
Targovax’s ONCOS-102 receives FDA fast track designation for malignant pleural mesothelioma treatment
In a significant development for cancer treatment, Targovax, a Norwegian biotech firm specializing in immune-oncology, has announced that…
FDA approves Opdivo and Cabometyx combo for advanced kidney cancer treatment
The U.S. Food and Drug Administration (FDA) has officially approved the combination of Bristol Myers Squibb’s Opdivo (nivolumab)…
ViiV Healthcare’s Cabenuva secures FDA approval for HIV treatment
ViiV Healthcare has received FDA approval for Cabenuva, a long-acting treatment regimen for HIV-1 infection in adult patients.…
Janssen Pharmaceutical’s DARZALEX FASPRO gains FDA approval for AL amyloidosis treatment
Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured FDA approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj),…