New Drug Application News and Research

RSS
NeuroDerm starts patient enrollment in long-term safety study of ND0612 for treatment of Parkinson’s disease

NeuroDerm starts patient enrollment in long-term safety study of ND0612 for treatment of Parkinson’s disease

FDA announces availability of investigational test to screen donated blood for Zika virus

FDA announces availability of investigational test to screen donated blood for Zika virus

Breckenridge Pharmaceutical announces final FDA approval for Gabapentin Oral Solution

Breckenridge Pharmaceutical announces final FDA approval for Gabapentin Oral Solution

Aralez resubmits NDA package for YOSPRALA to FDA

Aralez resubmits NDA package for YOSPRALA to FDA

WRAIR researchers publish results from Plasmodium vivax malaria vaccine study

WRAIR researchers publish results from Plasmodium vivax malaria vaccine study

Teligent obtains FDA approval for Desoximetasone Ointment USP 0.25%

Teligent obtains FDA approval for Desoximetasone Ointment USP 0.25%

Pfizer’s IBRANCE (palbociclib) now approved for use in women with HR+, HER2- metastatic breast cancer

Pfizer’s IBRANCE (palbociclib) now approved for use in women with HR+, HER2- metastatic breast cancer

Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

FDA approves Lannett's ANDA for Sumatriptan Nasal Spray USP

FDA approves Lannett's ANDA for Sumatriptan Nasal Spray USP

Patient enrollment completed in vepoloxamer Phase 3 study for treatment of sickle cell disease

Patient enrollment completed in vepoloxamer Phase 3 study for treatment of sickle cell disease

Mylan announces FDA's acceptance of ANDA filing for generic Advair Diskus

Mylan announces FDA's acceptance of ANDA filing for generic Advair Diskus

CTI BioPharma announces Q4 and FY 2015 earnings

CTI BioPharma announces Q4 and FY 2015 earnings

Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

Allergan's sNDA for TEFLARO (ceftaroline fosamil) accepted by FDA

Neurocrine Biosciences reports net loss of $29.3 million for fourth quarter 2015

Neurocrine Biosciences reports net loss of $29.3 million for fourth quarter 2015

Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

Shire announces resubmission of lifitegrast NDA to FDA for treatment of dry eye disease in adults

FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

Mylan releases generic version of Felbatol Tablets in U.S.

Mylan releases generic version of Felbatol Tablets in U.S.

Mylan announces U.S. launch of generic Ortho Tri-Cyclen Lo Tablets

Mylan announces U.S. launch of generic Ortho Tri-Cyclen Lo Tablets

First patient enrolled in Phase 3 efficacy trial of CAM2038 for opioid dependence

First patient enrolled in Phase 3 efficacy trial of CAM2038 for opioid dependence

Amarantus seeks FDA's Rare Pediatric Disease Designation and ODD to treat GCMN with Engineered Skin Substitute

Amarantus seeks FDA's Rare Pediatric Disease Designation and ODD to treat GCMN with Engineered Skin Substitute