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Sorrento receives FDA clearance Phase 2 study for Sti-3031 ; Advanced Urothelial Carcinoma

Sorrento intends to combine a variety of its proprietary mAbs in conjunction with the ADNAB technology platform...
Apr 28

Cytocom receives FDA clearance of IND for Phase 2 clinical trial of CYTO-205 as treatment for COVID-19

Latest FDA News Update...
Mar 18

Sorrento receives USFDA clearance to start a clinical trial of Anti-CD47 antibody

Sorrento receives USFDA clearance to start a clinical trial of Anti-CD47 Antibody, discovered from fully human G-MAB library, for treatment of multiple malignancies ...
Mar 03

Roche receives first USFDA clearance for urine sample type for BK virus quantitative test

Roche receives first USFDA clearance for urine sample type for BK virus quantitative test to aid in the improvement of care for transplant patients ...
Feb 13

Fortress Biotech announces US FDA has granted breakthrough therapy designation for CUTX-101

Fortress Biotech declares US FDA has granted breakthrough therapy designation for CUTX-101, Copper Histidinate, for the treatment of Menkes Disease ...
Dec 16

Kronos Bio announces US FDA clearance of IND application for KB-0742

The company plans to begin a Phase 1/2 clinical trial of KB-0742 in patients with advanced solid tumours in the first quarter of ...
Dec 08

Orchard Therapeutics announces US FDA clearance of IND application for OTL-200 for metachromatic leukodystrophy

The company believes that OTL-200 offers tremendous potential to transform the lives of many young patients with MLD...
Nov 21

Eli Lilly's bamlanivimab receives US FDA clearance for the treatment of COVID-19

Eli Lilly’s neutralizing antibody bamlanivimab receives US FDA emergency use authorization for the treatment of recently diagnosed COVID-19...
Nov 12

Sedor Pharmaceuticals receives US FDA approval for SESQUIENT

Ligand’s Partner Sedor Pharmaceuticals receives US FDA approval for SESQUIENT for the treatment of status epilepticus in adult and paediatric patients ...
Nov 07

Everest Medicines receives approval of CTA by China NMPA for phase 3 registration trial of Trodelvy

This trial will enroll approximately 330 HR+/HER2- mBC patients in Mainland China, Taiwan and South Korea...
Nov 02

Janssen submits new drug application to U.S. FDA for treatment of schizophrenia in adults

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Nov 02

Janssen submits new drug application to U.S. FDA for treatment of schizophrenia in adults

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Nov 02

Genprex receives conditional US FDA acceptance for the treatment of non-small cell lung cancer

Genprex receives conditional FDA acceptance of proprietary name REQORSA for lead drug candidate for the treatment of non-small cell lung cancer ...
Oct 30

Roche receives US FDA approval for the cobas EGFR mutation test v2

Roche receives FDA approval for the cobas EGFR mutation test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with ...
Oct 30

Tyber Medical receives US FDA clearance on foot and ankle plating systems

The comprehensive portfolio is the first of several planned plating releases for the distal extremities ...
Oct 21

Aprea Therapeutics receives FDA clearance to initiate Phase 1 study of APR-548

Karolinska Development's portfolio company Aprea Therapeutics receives FDA clearance to initiate Phase 1 study of APR-548 ...
Oct 08

Vaxart announces FDA clearance of IND application for oral COVID-19 Vaccine

Oral Covid vaccine gains ground...
Sep 18

Neuraptive Therapeutics Announces FDA Clearance of IND Application

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Apr 30

AI Saving Brain: FDA Clears Aidoc's Complete AI Stroke Package

Fourth FDA clearance makes Aidoc the comprehensive solution for radiology AI ...
Jan 14

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