Teva Pharmaceutical Industries and Active Biotech have announced that both companies remain committed to the Nerventra(laquinimod)clinical development program for multiple sclerosis(MS)following the announcement of a negative opinion for ...
Tags: Medicine, clinical studies, Nerventra
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
European Medicines Agency's (EMA) the Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion for AstraZeneca and Bristol-Myers Squibb's of Xigduo for adults aged 18 and older with type 2 diabetes mellitus. The ...
Swiss drugmaker Novartis has announced that once-daily dual bronchodilator, Ultibro Breezhaler (QVA149), has achieved positive CHMP opinion for the treatment of chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was ...
Japan-based Takeda Pharma has received positive CHMP opinion for its three new type 2 diabetes therapies from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The therapies include Vipidia ...
Tags: Therapies, CHMP Opinion
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion for European marketing authorization of Pfizer's Xeljanz (tofacitinib citrate). Xeljanz is a novel, oral Janus kinase ...
The European Medicines Agency has cleared Roche's RoACTEMRA for the treatment of a rare form of arthritis, polyarticular juvenile idiopathic arthritis (PJIA), in children aged two years and above. Approved for use alone or in combination ...
Tags: Arthritis Drug, Medicine
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Celgene International's oral anti-cancer therapy Pomalidomide. The positive results from the MM-003 study of ...
The European Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinion for Aegerion Pharmaceuticals' marketing authorization for Lojuxta (lomitapide) hard capsules. If approved, Lojuxta will be indicated for adult ...
Tags: Marketing Authorization, Medicine
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced positive opinion for conditional approval of Curis' Erivedge in European Union. Erivedge (vismodegib) is used to treat adults with ...
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' marketing authorization application (MAA) for stribild. The once-daily, single tablet regimen ...
Tags: Stribild drug, Medicines, Medicine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Genzyme's oral Aubagio (teriflunomide) for relapsing-remitting multiple sclerosis (MS). Aubagio did not ...
Pfizer's bosutinib has received positive opinion for the conditional marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The bosutinib positive CHMP opinion is concerned with ...
Savient Pharmaceuticals's Krystexxa (pegloticase) has received positive opinion recommending approval of a marketing authorization from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following ...
Tags: Savient Krystexxa, positive CHMP, EMA
Eisai has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Fycompa (perampanel), an AMPA receptor antagonist. Fycompa (perampanel) is an adjunctive treatment of ...
Tags: fycompa, perampanel, epilepsy, zonisamide