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
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional approval for Takeda Pharmaceuticals and Millennium adcetris (brentuximab vedotin) in Europe. If the CHMP ...
Tags: CHMP, refractory CD30 positive Hodgkin lymphoma, sALCL
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
Takeda Pharmaceutical Company and NPS Pharmaceuticals have announced positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Teduglutide (Revestive) for patients with short bowel syndrome (SBS). Teduglutide, ...
Tags: short bowel syndrome, teduglutide, glucagon-like peptide 2
Sosei Group Corporation,Japan, has received a positive opinion for its Seebri Breezhaler (glycopyrronium bromide/NVA237),a type of bronchodilator, from European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). ...
Tags: Seebri Breezhaler, bronchodilator, CHMP, Positive Chmp Opinion
Novartis has planned to update the Rasilez's labelling to include contraindications against combined use with a number of products. The company will follow the advice of the EMA's Committee for Medicinal Products for Human Use (CHMP) in ...
Tags: Novartis, CHMP, Rasilez's labelling
Pfizer has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for crizotinib to treat adults with previously treated anaplastic lymphoma kinase (ALK)-positive ...
Tags: Pfizer, CHMP, anaplastic lymphoma kinase
Bexsero, Novartis' Meningococcal Group B Vaccine, has won a positive opinion from European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion indicates the use of the broad coverage vaccine in ...
Pfizer has received positive opinion from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency for the marketing authorization of axitinib to treat patients with advanced renal cell carcinoma. The European ...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Astellas Pharma Europe's Betmigatm (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency ...
Tags: symptomatic treatment of urgency, pharmaceutical product
Novartis' Exjade has received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Exjade is used to treat chronic iron overload requiring chelation therapy when ...
Tags: Medicinal Products, iron overload, CHMP recommendation
Ferrer Internacional has decided to withdraw the marketing authorisation application (MAA) for Egrifta (tesamorelin) 2mg, powder for solution for injection in Europe. Ferrer formally notified the European Medicines Agency of its decision. ...
Tags: DME, healthcare products, pSivida
Eli Lilly and Company and Avid Radiopharmaceuticals have gained positive CHMP opinion for Amyvid (Florbetapir F 18 injection) for the use as a diagnostic tool for positron emission tomography (PET) imaging of beta-amyloid plaque density in ...
Tags: Amyvid, Positive CHMP Opinion, Cognitive Impairment Diagnosis
The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AMAG Pharmaceuticals' ferumoxytol, an iron deficiency anemia (IDA) therapy. The intravenous (IV) iron therapy, indicated for the treatment of ...
Tags: AMAG Pharmaceuticals, iron deficiency anemia(IDA)therapy
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended SkyePharma's flutiform (fluticasone propionate/formoterol fumarate) for European marketing approval. Flutiform is a ...
Tags: Skyepharma Flutiform, SkyePharma, long-acting beta-agonist