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 Food and Drug Administration (FDA) has accepted Dynavax Technologies' heplisav biologics license application (BLA) for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of ...
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 ...
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 marketing authorization for Pharmaxis' Bronchitol as an add on therapy to cystic fibrosis (CF). The company developed Bronchitol to aid clear the airways of CF patients. Pharmaxis CEO Alan Robertson ...
Tags: cystic fibrosis, CF, Pharmaxis'Bronchitol
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
Genzyme, a Sanofi company, has submitted a new drug application to the FDA seeking approval for KYNAMRO for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The submission is based on trial in which ...
Tags: KYNAMRO, homozygous familial hypercholesterolemia, HoFH
Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS). In collaboration with ...
Tags: sBLA, relapsing multiple sclerosis, RMS
Bayer HealthCare has filed a new drug application (NDA) with the FDA seeking approval for the oral multi-kinase inhibitor regorafenib to treat patients with metastatic colorectal cancer (mCRC). The company has even filed an application ...
Tags: oral multi-kinase inhibitor regorafenib, metastatic colorectal cancer
Basilea Pharmaceutica has submitted a marketing authorization application (MAA) under the European decentralized procedure for its novel investigational antibiotic, ceftobiprole, to treat pneumonia in hospitals. The submission of the ...
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
Takeda Pharmaceutical Company and Millennium: The Takeda Oncology Company have won European conditional marketing authorization for Adcetris (brentuximab vedotin). Adcetris is indicated for use in adult patients with relapsed or ...
Tags: adcetris, antibody-drug conjugate, Brentuximab vedotin, sALCL
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
NewLink Genetics HyperAcute-Pancreas Immunotherapy (algenpantucel-L) has gained European orphan designation. Orphan designation provides NewLink with access to multiple incentives for drug development in EU. Incentives include decreased ...
Tags: algenpantucel-L, NewLink Genetics, HyperAcute-Pancreas Immunotherapy