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61-75 of 2284 results
ProQR secures FDA fast track designation for QR-010 to treat Cystic Fibrosis
ProQR Therapeutics has received Fast Track designation from the Food and Drug Administration (FDA) for its molecule QR-010 that is in clinical development for the treatment of patients with CF due to the ∆F508 mutation.
Drug Research > Drug Delivery > News
Samsung Bioepis' Humira biosimilar application accepted for review in Europe
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted for review Samsung Bioepis’ marketing authorization application (MAA) for SB5, an adalimumab biosimilar candidate referencing AbbVie’s Humira.
Drug Research > Drug Delivery > News
Advanced Proteome formulates strategic plan featuring novel antibody program
Advanced Proteome Therapeutics has announced plans bearing on its site-specific protein modification technology as it applies to therapeutic antibodies.
Drug Research > Drug Delivery > News
Provectus Biopharmaceuticals establishes Australian subsidiary
Provectus Biopharmaceuticals, a clinical-stage oncology and dermatology biopharmaceutical company, has formed an Australian subsidiary, Provectus Biopharmaceuticals Australia.
Drug Research > Drug Delivery > News
Mylan launches generic Fenoglide tablets in US
Mylan announced the US launch of Fenofibrate Tablets USP, 40 mg and 120 mg, which is a generic version of Santarus's Fenoglide.
Drug Research > Drug Delivery > News
AlliancePharma signs definitive agreements to acquire three companies
AlliancePharma has entered into definitive agreements to acquire three companies and has also entered into a private placement agreement with a healthcare-focused private equity fund.
Drug Research > Drug Delivery > News
FDA grants orphan drug status to Araim’s ARA 290 to treat sarcoidosis
By PBR Staff Writer
Araim Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for ARA 290 to treat sarcoidosis.
Drug Research > Drug Delivery > News
Allergan gets positive opinion from Swedish MPA for Belkyra to treat patients with submental fullness
By PBR Staff Writer
Allergan has received a positive opinion from the Swedish Medical Products Agency (MPA) for Belkyra to treat patients with submental fullness.
Drug Research > Drug Delivery > News
Kitov's KIT-302 drug achieves manufacturing milestone ahead of planned NDA Filing with FDA
Kitov Pharmaceuticals announced that Dexcel Pharma, Kitov's manufacturing partner, has successfully completed an initial stability study for its lead drug candidate KIT-302.
Drug Research > Drug Delivery > News
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
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.
Drug Research > Drug Delivery > News
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
61-75 of 2284 results