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FDA approves changes to SABRIL REMS Program Lundbeck announced that the U.S. Food and Drug Administration (FDA) approved a modified Risk Evaluation and Mitigation Strategy (REMS) for Sabril® (vigabatrin).
Drug Research > Drug Delivery > News
Mylan launches generic Avodart capsules in US Mylan announced the US launch of Dutasteride Capsules, 0.5 mg, the generic version of GlaxoSmithKline's Avodart Capsules.
Drug Research > Drug Delivery > News US authorities recommended against AstraZeneca’s flu vaccine Quadrivalent By PBR Staff Writer
The Advisory Committee on Immunization Practices (ACIP) of US Centers for Disease Control and Prevention (CDC) has recommended not to use live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine during the 2016-2017 flu season.
Drug Research > Drug Delivery > News
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US House passes $1.1bn bill to fight Zika virus
By PBR Staff Writer
The US House of Representatives has approved a bill to provide $1.1bn funding to combat the mosquito-borne Zika virus.
Drug Research > Drug Delivery > News
GlobalData expects IPF market to more than treble to $3.2bn by 2025
By PBR Staff Writer
Research and consulting firm GlobalData expects that the idiopathic pulmonary fibrosis (IPF) market will increase to $3.2bn by 2025 from just more than $900m in 2015.
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Adaptimmune receives positive opinion for orphan drug status in EU for SPEAR T-cell therapy
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending Adaptimmune Therapeutics' SPEAR T-cell therapy targeting NY-ESO for designation as an orphan medicinal product for the treatment of soft tissue sarcoma, a solid tumor cancer.
Drug Research > Drug Delivery > News
Ariad Pharmaceuticals seeks FDA approval for brigatinib lung cancer drug
By PBR Staff Writer
Ariad Pharmaceuticals has started a new drug application submission in the US for approval of brigatinib in relapsed, anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC).
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Bausch + Lomb launches PreserVision AREDS 2 Formula + Multivitamin
Valeant Pharmaceuticals International's subsidiary, Bausch + Lomb launched new PreserVision® AREDS 2 Formula + Multivitamin.
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PeptiDream earns milestone for initiation of clinical development for BMS’ first collaboration product candidate
PeptiDream, a public Tokyo-based biopharmaceutical company, has earned a milestone for the dosing of a first patient in a clinical trial by its alliance partner, Bristol-Myers Squibb Company (BMS).
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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).
Drug Research > Drug Delivery > News
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.
Drug Research > Drug Delivery > News
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