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 ...
Lupin Pharmaceuticals has gained FDA approval for its Norgestimate and Ethinyl Estradiol tablets, 0.18mg/0.025mg, 0.215mg/0.025mg, and 0.25mg/0.025mg. Norgestimate and Ethinyl Estradiol tablets are indicated for the prevention of ...
Tags: Lupin Pharmaceuticals, norgestimate and ethinyl estradiol tablets
Glenmark Generics, a US subsidiary of Glenmark Pharmaceuticals, has received final FDA approval for its abbreviated new drug application for Norgestimate and Ethinyl Estradiol tablets USP 0.25mg/0.035mg. The product is the generic version ...
Janssen Pharmaceuticals has settled its legal cases with 36 states and the District of Columbia regarding promotional and marketing practices for its atypical antipsychotic prescription medication Risperdal. The company will shell out ...
Tags: atypical antipsychotic prescription medication, rispedal
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) of Itraconazole capsules, 100mg, the generic version of Janssen Pharmaceutical's Sporanox capsules. The generic Sporanox is indicated for the ...
Janssen Research & Development has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban), an oral anticoagulant. Janssen said the drug is used to treat ...
Tags: Xarelto, rivaroxaban, DVT, pulmonary embolism, VTE
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
Janssen Research & Development has submitted a new drug application (NDA) to the FDA for canagliflozin to treat adult patients with type 2 diabetes. The filing is based on a global Phase III clinical development program, including nine ...
Tags: Janssen Research&Development, SGLT2, cardiovascular study
Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval. Bedaquiline,an investigational drug administered orally,is used as part of ...
Tags: FDA, new drug application, investigational drug, pulmonary
CLC bio has implemented specialized antibody engineering and selection software for Crucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, that integrates with CLC bio's bioinformatics platform. The specialized module ...
Tags: CLC bio, bioinformatics platform
Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...
Janssen Biotech, a Johnson & Johnson company, has executed a license and development agreement for an investigational anti-cancer agent, daratumumab (HuMax-CD38), with Genmab. Daratumumab is a human CD38 monoclonal antibody which is ...
Tags: Daratumumab License, license and development agreement, anti-cancer
Janssen Biotech has signed a license agreement with Astellas Pharma for the worldwide development and commercialization of ASP015K, except in Japan. Astellas will continue development and commercialization of ASP015K in Japan. ASP015K, ...
Tags: Janssen Biotech, Astellas Pharma, license agreement, ASP015K