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121-135 of 2292 results
Mylan launches generic version of Apresoline injection in US
Mylan announced the US launch of Hydralazine Hydrochloride Injection USP, 20 mg/mL, which is a generic version of Novartis' Apresoline Injection, 20 mg/mL.
Drug Research > Drug Delivery > News
Concert Pharmaceuticals unveils CTP-543 to treat alopecia areata
Concert Pharmaceuticals has announced its next product candidate, CTP-543, for the treatment of alopecia areata.
Drug Research > Drug Delivery > News
Veristat acquires UK-based CRO, Spero Oncology
Veristat, a full service Clinical Research Organization (CRO), is expanding its clinical research offerings into Europe through the acquisition of UK-based CRO, Spero Oncology.
Drug Research > Drug Delivery > News
Heritage Pharmaceuticals issues product safety warning counterfeit drug product BiCNU
Heritage Pharmaceuticals announced that it recently became aware of the existence of a counterfeit drug product labeled as BiCNU (Carmustine for Injection) 100mg that has been sold and distributed outside of the US.
Drug Research > Drug Delivery > News
Ocular completes end-of-phase 2 review with FDA for OTX-TP for glaucoma and ocular hypertension
Ocular Therapeutix has completed its End-of-Phase 2 review with the US Food and Drug Administration (FDA) for its OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma and ocular hypertension.
Drug Research > Drug Delivery > News
Chinese Patent Office plans to grant patent relating to Immunicum's cancer immune primer INTUVAX
The Chinese Patent Office (SIPO) intends to grant a patent relating to Immunicum's cancer immune primer, INTUVAX.
Drug Research > Drug Delivery > News
Galapagos reports 20-week results from FITZROY study with JAK1 inhibitor filgotinib in Crohn's disease
Galapagos reported 20-week results from its FITZROY study with the investigational, selective JAK1 inhibitor filgotinib in Crohn's disease.
Drug Research > Drug Delivery > News
Tris Pharma launches DYANAVEL XR oral suspension, CII to treat Children with ADHD
Tris Pharma has launched DYANAVEL XR (amphetamine), CII, the first and only extended-release liquid amphetamine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older.
Drug Research > Drug Delivery > News
FDA finds no finds no deficiency with Heron Therapeutics' Sustol NDA
By PBR Staff Writer
The US Food and Drug Administration (FDA) has indicated that there are no substantive deficiencies in Heron Therapeutics' new drug application (NDA) for Sustol (granisetron) Injection (extended release) to treat acute and delayed chemotherapy-induced nausea and vomiting (CINV).
Drug Research > Drug Delivery > News
WHO expert panel recommends use of Sanofi Pasteur's dengue vaccine in endemic countries
By PBR Staff Writer
The World Health Organization's (WHO) strategic advisory group of experts had recommended the use of Sanofi Pasteur's Dengvaxia dengue vaccine in endemic countries.
Drug Research > Drug Delivery > News
Shire submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets
Shire has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a new, alternate formulation of Vyvanse (lisdexamfetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule.
Drug Research > Drug Delivery > News
Synthon secures approval for glatiramer acetate 20 mg/mL in Europe
Synthon has successfully concluded the decentralized procedures for glatiramer acetate, a therapeutically equivalent version of the originator medicine Copaxone for the treatment of relapsing remitting multiple sclerosis (RRMS).
Drug Research > Drug Delivery > News
Boehringer Ingelheim's Giotrif secures new NSCLC licence in Europe
The European Commission (EC) has granted marketing authorisation for Boehringer Ingelheim's Giotrif (afatinib) for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy.
Drug Research > Drug Delivery > News
FDA places clinical hold on late-stage study on IONIS-TTRRx
Ionis Pharmaceuticals provided an update on the IONIS-TTRRx program.
Drug Research > Drug Delivery > News
FDA accepts Adaptimmune's NDA for affinity enhanced T-Cell therapy targeting AFP in liver cancer
The US Food and Drug Administration (FDA) has accepted Adaptimmune Therapeutics' investigational new drug (IND) application for autologous genetically modified T-cells expressing affinity enhanced T-cell receptors (TCRs) specific for alpha fetoprotein (AFP) in patients with locally advanced or metastatic hepatocellular carcinoma, the sixth most common cancer worldwide.
Drug Research > Drug Delivery > News
121-135 of 2292 results