New Drug Application News and Research

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FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T

FDA grants Rare Pediatric Disease Designation for Immusoft’s Iduronicrin genleukocel-T

FDA and EMA accept Novartis' regulatory application for siponimod to treat SPMS in adults

FDA and EMA accept Novartis' regulatory application for siponimod to treat SPMS in adults

Genentech announces Phase III study results of baloxavir marboxil in people at high risk of flu

Genentech announces Phase III study results of baloxavir marboxil in people at high risk of flu

Cidara initiates Phase 3 clinical trial to evaluate efficacy, safety of rezafungin to treat invasive candidiasis

Cidara initiates Phase 3 clinical trial to evaluate efficacy, safety of rezafungin to treat invasive candidiasis

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

FDA grants Orphan Drug Designation to Myelo001 for treatment of Acute Radiation Syndrome

FDA grants Orphan Drug Designation to Myelo001 for treatment of Acute Radiation Syndrome

FDA approves Cassipa sublingual film for maintenance treatment of opioid dependence

FDA approves Cassipa sublingual film for maintenance treatment of opioid dependence

NCCN updates Clinical Practice Guidelines to include new recommendations for CABOMETYX tablets

NCCN updates Clinical Practice Guidelines to include new recommendations for CABOMETYX tablets

Verastem doses first patient in Phase I/II clinical trial of duvelisib in combination with venetoclax

Verastem doses first patient in Phase I/II clinical trial of duvelisib in combination with venetoclax

Sunovion receives Complete Response Letter from FDA for dasotraline NDA

Sunovion receives Complete Response Letter from FDA for dasotraline NDA

Researchers publish new paper on developing vaccine candidates for Helminthic parasites

Researchers publish new paper on developing vaccine candidates for Helminthic parasites

FDA grants approval for first generic version of epinephrine auto-injector

FDA grants approval for first generic version of epinephrine auto-injector

CFDA accepts Ascletis’ NDA for first all-oral HCV treatment

CFDA accepts Ascletis’ NDA for first all-oral HCV treatment

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

Pivotal study of dasotraline in adults with binge eating disorder meets primary endpoint

AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

AbbVie submits supplemental NDA to FDA for venetoclax to treat acute myeloid leukemia

Ocular Therapeutix resubmits NDA for DEXTENZA

Ocular Therapeutix resubmits NDA for DEXTENZA

PanOptica doses first patient in Phase 1/2 dose-ranging clinical trial of PAN-90806

PanOptica doses first patient in Phase 1/2 dose-ranging clinical trial of PAN-90806

KARL STORZ launches new PDD Blue Cystoscopy system for enhanced detection of NMIBC tumors

KARL STORZ launches new PDD Blue Cystoscopy system for enhanced detection of NMIBC tumors

FDA clears Turnstone Biologics' IND for immunotherapy targeting HPV positive solid tumors

FDA clears Turnstone Biologics' IND for immunotherapy targeting HPV positive solid tumors

Celgene announces regulatory information about investigational compound for relapsing multiple sclerosis

Celgene announces regulatory information about investigational compound for relapsing multiple sclerosis