Janssen's Zytiga indicated for metastatic castration-resistant prostate cancer(mCRPC),has won FDA approval for use in patients who have not received chemotherapy. The oral,once-daily medication was previously used in combination with ...
Janssen Biotech and Janssen Biologics are seeking approval for Stelara in the US and Europe for the treatment of active psoriatic arthritis. A supplemental biologics license application (sBLA) was submitted to the FDA and a Type II ...
Roche Group member, Genentech has received US Food and Drug Administration (FDA) official approval of priority review designation for trastuzumab emtansine Biologics License Application (BLA). Trastuzumab Emtansine is designed to treat ...
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
US based Ariad Pharmaceuticals has submitted New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib for the approval of US Food and Drug Administration (FDA). Ponatinib is indicated for patients with resistant or ...
Tags: BCR-ABL inhibitor, CML, Ph+ALL
The European Commission has granted conditional marketing authorization for Pfizer’s Xalkori (crizotinib) to treat anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) in the European Union (EU). ...
Tags: Xalkori, crizotinib, anaplastic lymphoma kinase, ALK
The US Food and Drug Administration (FDA) has granted accelerated approval to Talon Therapeutics' Marqibo (vinCRIStine sulfate LIPOSOME injection). Marqibo, a sphingomyelin/cholesterol liposome-encapsulated formulation of vincristine ...
European Medicines Agency (EMA) has accepted to review Pfizer's marketing authorization application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE). BZA/CE is designed for postmenopausal women with a uterus for the treatment of ...
Tags: bazedoxifene conjugated estrogens, BZA/CE, estrogen deficiency symptoms
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
Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as ...
Tags: investigational drug bedaquiline, multi-drug resistant tuberculosis
Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi ...
Tags: Simponi, golimumab, active ulcerative colitis, anti-tumor necrosis factor
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
The Medicines Control Council (MCC) of South Africa has selected Extedo's new solution based on EURS is Yours for its reviewing and validation project called ERES. The Extedo solution will validate, import, and review electronic ...
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
Auxilium Pharmaceuticals and Actelion Pharmaceuticals Canada have announced Health Canada notice of compliance (approval) for Xiaflex (collagenase clostridium histolyticum or CCH) to treat Dupuytren's contracture in adults with a palpable ...