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FDA accepts NLS Pharma's IND for phase II study of Mazindol in adults with ADHD
FDA has accepted an investigational new drug (IND) submitted by NLS Pharma, a Swiss biotech group developing next-generation ADHD therapies for a phase II proof-of-concept clinical trial evaluating the use of Mazindol in adults with Attention Deficit Hyperactivity Disorder (ADHD).
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Therapix Biosciences files application with FDA to approve orphan designation for THX-RS01 drug
Therapix Biosciences has filed an application with the U.S. Food and Drug Administration to approve an orphan drug designation for a drug (THX-RS01) developed based on the entourage technology, which combines cannabinoid substances in treating Tourette syndrome.
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Teva voluntarily suspends marketing for ZECUITY in US
Teva Pharmaceutical Industries announced that it will voluntarily suspend sales, marketing and distribution of ZECUITY (sumatriptan iontophoretic transdermal system).
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Shire secures FDA breakthrough therapy designation for two rare GI drugs
By PBR Staff Writer
Shire has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for two investigational products, SHP621 and SHP625, for rare gastrointestinal (GI) conditions.
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FDA accepts to review sNDA for 72 mcg dose of linaclotide in chronic idiopathic constipation
Ironwood Pharmaceuticals and Allergan announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC).
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Clinigen, Basilea start MA program for isavuconazole to treat patients with invasive fungal infections in Europe
Clinigen Group and Basilea Pharmaceutica International have initiated a Managed Access program for isavuconazole to treat patients with invasive fungal infections in those European countries where isavuconazole has been approved but is not yet commercially available.
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Lion Biotechnologies closes $100m private financing
Lion Biotechnologies has closed its previously announced private financing with institutional and other accredited investors.
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Insmed withdraws marketing authorization application for ARIKAYCE in Europe
Insmed has withdrawn its Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for ARIKAYCE for the treatment of nontuberculous mycobacteria (NTM) lung disease.
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FDA grants orphan drug designation to Debio 1143 to treat ovarian cancer
The FDA Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Debiopharm International's Debio 1143 for treatment of Ovarian Cancer.
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Genisphere signs collaborative research, option to license deal with MedImmune
Genisphere, provider of the 3DNA drug delivery platform, has executed a collaborative research and option to license agreement with MedImmune, the global biologics research and development arm of AstraZeneca.
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Immunovaccine announces preclinical collaboration for DepoVax-based malaria vaccine
Immunovaccine has announced a preclinical collaboration with The University of Edinburgh’s Center for Immunity, Infection and Evolution (CIIE).
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Innovus to request regulatory guidance for FlutiCare product filing in Europe to treat allergic rhinitis
Innovus Pharmaceuticals announced that it will seek regulatory guidance from the United Kingdom's MHRA as a Reference Member State in Europe before submitting its European application for its FlutiCare™ (50mcg fluticasone propionate) 60 and 120 sprays/bottle.
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Mylan launches first generic of Doxycycline Hyclate DR tablets, 50 mg in US
Mylan announced the U.S. launch of Doxycycline Hyclate Delayed-Release (DR) Tablets USP, 50 mg, a generic version of Mayne's Doxteric, which is being marketed as Doryx.
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Kite Pharma granted access to PRIME regulatory support for KTE-C19 to treat chemorefractory DLBCL
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to Kite Pharma's newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL).
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European CHMP adopts positive opinion for Gilead’s Epclusa to treat all genotypes of chronic hepatitis C
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on Gilead Sciences' Marketing Authorization Application (MAA) for Epclusa, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection.
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