Drugdiscovery >> Drugs >> News
6037
Views
New Drug Application for Delcath's drug rejected - drugdiscovery.com
New Drug Application for Delcath's drug rejected - drugdiscovery.com


The FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Delcath Systems’ drug MelblezTM Kit, for the treatment of patients with unresectable ocular melanoma metastatic to the liver. More trials needed to establish the safety and efficacy of the drug.
Read More >>


Tags: new drug application, NDA, Delcath, ocular melanoma, drug, Melblez, melphalan - September 14, 2013
Related Articles
1969
Views
New Drug Application for idelalisib New Drug Application for idelalisib
Gilead Sciences’ drug Idelalisib is an investigational, targeted, oral inhibitor of PI3K delta. If approved, it will be used for the treatment of indolent non-Hodgkin's lymphoma (iNHL). Read More >>

Tags: Gilead, idelalisib, new drug application, non-Hodgkin lymphoma

4022
Views
Sanofi decides to withdraw the lixisenatide New Drug Application Sanofi decides to withdraw the lixisenatide New Drug Application
Following discussions with the FDA regarding its proposed process for the review of interim data, Sanofi decided to wait with the NDA after completion of the ELIXA CV study. Read More >>

Tags: Sanofi, new drug application,lixisenatide, ELIXA

4142
Views
New Drug Application for AstraZeneca's hypertriglyceridaemia drug New Drug Application for AstraZeneca's hypertriglyceridaemia drug
The new drug application (NDA) for AstraZeneca's investigational hypertriglyceridaemia treatment, Epanova, has been accepted for standard review by the FDA. Read More >>

Tags: New Drug Application, AstraZeneca, hypertriglyceridaemia, drug, Epanova, FDA

2516
Views
New Drug Application for PENNSAID 2% accepted for FDA review New Drug Application for PENNSAID 2% accepted for FDA review
Mallinckrodt’s drug MNK-395 , or PENNSAID (diclofenac sodium topical solution) 2% is studied in the treatment of the osteoarthritis pain of the knee. Read More >>

Tags: Mallinckrodt, MNK-395, PENNSAID, diclofenac sodium, topical solution, pennsaid, pain, osteoarthritis, knee, FDA

1251
Views
Xarelto was rejected again Xarelto was rejected again
Xarelto is Bayer's and Johnson & Johnson's oral anticoagulant. FDA has voted agains it for the second time due to ACS. The drug said to be a treatment for acute coronary syndrome. Read More >>

Tags: acute coronary syndrome, acs, anticoagulant

4677
Views
 FDA accepts new drug application for  Merck's fertility treatment FDA accepts new drug application for Merck's fertility treatment
The new drug application (NDA) for Merck’s investigational fertility treatment, corifollitropin alfa, has been accepted for standard review by the FDA. If approved, the drug will be used in women Read More >>

Tags: Merck, assisted reproductive technology, fertility treatment, controlled ovarian stimulation, FDA, corifollitropin alfa

8051
Views
SOLIAIR™: New Respiratory Diseases Drug Discovery! SOLIAIR™: New Respiratory Diseases Drug Discovery!
SOLIAIR™ is a food supplement which has reported beneficial impact. Patients taking SOLIAIR™ reported a decrease in seasonal infections of the respiratory tract. The SOLIAIR™ is free of side eff Read More >>

Tags: Drug Development,Drug Discovery,Medicine Development,COPD Treatment,Asthma Solution,Bronchitis Therapy,Respiratory Diseases,Lung Infections,Breathing Disorders,healthcare investment,Drug Innovation,

2230
Views
FDA accepts Endo’s long-acting testosterone injection application FDA accepts Endo’s long-acting testosterone injection application
The FDA has accepted for review new data for Endo’s long-acting testosterone injection- Aveed, intended for the treatment of hypogonadism. The ruling on the drug will be made by the end of February Read More >>

Tags: Endo, aveed, hypogonadism, testosterone injection, FDA approval

12983
Views
Orphan Drug Designation for Hemophilia B drug ALN-AT3 Orphan Drug Designation for Hemophilia B drug ALN-AT3
FDA has approved an Orphan Drug Designation to Alnylam Pharmaceuticals’ drug ALN-AT3 for the treatment of hemophilia B. ALN AT3 is subcutaneously administered RNAi therapeutic which targets antith Read More >>

Tags: orphan drug, ALN-AT3, hemophilia B, antithrombin, RNAi,Alnylam

7923
Views
Orphan Drug Designation for HPV-associated anal cancer drug - ADXS-HPV Orphan Drug Designation for HPV-associated anal cancer drug - ADXS-HPV
FDA has approved an Orphan Drug Designation to Advaxis’ next generation immunotherapy drug ADXS-HPV for the treatment of human papillomavirus (HPV)-associated anal cancer. Read More >>

Tags: Advaxis, ADXS-HPV, HPV, anal cancer, human papillomavirus, immunotherapy, drug

MOST VIEWED
HOME | ABOUT | PRIVACY POLICY | TERMS & CONDITIONS | ADVERTISE | CONTACT
All rights reserved drugdiscovery.com 2013