New Drug Application News and Research

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U.S. FDA approves updated labeling for pan-genotypic single tablet regimen for HCV/HIV co-infected patients

U.S. FDA approves updated labeling for pan-genotypic single tablet regimen for HCV/HIV co-infected patients

FDA to expedite orphan drug processing queues

FDA to expedite orphan drug processing queues

FDA takes important steps to increase patient access to prescription drugs

FDA takes important steps to increase patient access to prescription drugs

LimTox online software tool provides information on drug hepatotoxicity

LimTox online software tool provides information on drug hepatotoxicity

FDA issues Complete Response Letter for Sunovion’s New Drug Application to treat COPD patients

FDA issues Complete Response Letter for Sunovion’s New Drug Application to treat COPD patients

Innovus Pharma announces launch of AllerVarx for relieving nasal, ocular symptoms in allergic patients

Innovus Pharma announces launch of AllerVarx for relieving nasal, ocular symptoms in allergic patients

New spherical nucleic acid drug crosses blood-brain barrier to target brain tumors in animals

New spherical nucleic acid drug crosses blood-brain barrier to target brain tumors in animals

UAB spinoff develops drug-resistant immunotherapy to combat solid tumors

UAB spinoff develops drug-resistant immunotherapy to combat solid tumors

Researchers use novel phage therapy to treat patient infected with multidrug-resistant bacterium

Researchers use novel phage therapy to treat patient infected with multidrug-resistant bacterium

Cannabidiol shows promise to reduce seizures for people with difficult-to-treat epilepsy

Cannabidiol shows promise to reduce seizures for people with difficult-to-treat epilepsy

OSU scientists find way to fight solid tumors using new cancer-drug delivery system

OSU scientists find way to fight solid tumors using new cancer-drug delivery system

Investigational compound for treating indolent lymphomas shows positive results in phase II clinical study

Investigational compound for treating indolent lymphomas shows positive results in phase II clinical study

Research highlights threat of Zika virus to donated blood supplies in the U.S

Research highlights threat of Zika virus to donated blood supplies in the U.S

GUMC launches phase II clinical study to examine safety of cancer drug for Parkinson's disease

GUMC launches phase II clinical study to examine safety of cancer drug for Parkinson's disease

Plant-based drug for hemophilia shows promise in animal models

Plant-based drug for hemophilia shows promise in animal models

Mylan announces U.S. launch of generic Zovia Tablets

Mylan announces U.S. launch of generic Zovia Tablets

Mylan announces U.S. launch of generic Concerta Tablets

Mylan announces U.S. launch of generic Concerta Tablets

MDA celebrates FDA approval of new spinal muscular atrophy drug

MDA celebrates FDA approval of new spinal muscular atrophy drug

GUMC receives FDA clearance to begin clinical study of cancer drug in patients with Alzheimer's disease

GUMC receives FDA clearance to begin clinical study of cancer drug in patients with Alzheimer's disease

Researchers make successful vaccine formulation that targets proteins linked to Alzheimer’s disease

Researchers make successful vaccine formulation that targets proteins linked to Alzheimer’s disease