New Drug Application News and Research

RSS
US tendency to arrogantly flout international ethical practice for patient trials abroad

US tendency to arrogantly flout international ethical practice for patient trials abroad

Approval for Temodar (temozolomide) capsules for newly diagnosed glioblastoma multiforme

Approval for Temodar (temozolomide) capsules for newly diagnosed glioblastoma multiforme

FDA has accepts new drug application for Exubera (inhaled human insulin powder)

FDA has accepts new drug application for Exubera (inhaled human insulin powder)

Experimental drug Revlimid showing promise as treatment for myelodysplastic syndrome (MDS)

Experimental drug Revlimid showing promise as treatment for myelodysplastic syndrome (MDS)

Launch date announced for Abraxane to treat metastatic breast cancer

Launch date announced for Abraxane to treat metastatic breast cancer

FDA knocks back anticancer drug Marqibo

FDA knocks back anticancer drug Marqibo

Velcade (bortezomib) phase III clinical trial initiated in patients with newly diagnosed multiple myeloma

Velcade (bortezomib) phase III clinical trial initiated in patients with newly diagnosed multiple myeloma

FDA clearance to test influenza vaccine, Fluviral

FDA clearance to test influenza vaccine, Fluviral

Information submitted via new drug applications could easily be made accessible to the public

Information submitted via new drug applications could easily be made accessible to the public

FDA accepts Genmab's Investigational New Drug Application for active rheumatoid arthritis treatment

FDA accepts Genmab's Investigational New Drug Application for active rheumatoid arthritis treatment

FDA approves Topigen's investigational New Drug Application for new inhalation drug to treat asthma

FDA approves Topigen's investigational New Drug Application for new inhalation drug to treat asthma

HHS purchases 1.2 million doses of GSK's Fluarix flu vaccine

HHS purchases 1.2 million doses of GSK's Fluarix flu vaccine

Pfizer submits regulatory filings for Revatio (sildenafil citrate) as a treatment for pulmonary arterial hypertension

Pfizer submits regulatory filings for Revatio (sildenafil citrate) as a treatment for pulmonary arterial hypertension

FDA approves Remodulin for the treatment of pulmonary arterial hypertension

FDA approves Remodulin for the treatment of pulmonary arterial hypertension

BiDil demonstrates significant improvement in survival rates in African American heart failure patients

BiDil demonstrates significant improvement in survival rates in African American heart failure patients

Wyeth shows new Phase III data about its investigational antibiotic, tigecycline

Wyeth shows new Phase III data about its investigational antibiotic, tigecycline

Maxim Pharmaceuticals to withdraw NDA for advanced malignant melanoma

Maxim Pharmaceuticals to withdraw NDA for advanced malignant melanoma

Tentative approval of testosterone gel product

Tentative approval of testosterone gel product

New Drug Application for Velac accepted for filing by the FDA

New Drug Application for Velac accepted for filing by the FDA

Boehringer Ingelheim  - New Drug Application (NDA) for tipranavir

Boehringer Ingelheim - New Drug Application (NDA) for tipranavir