Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs

Regulatory Affairs

FDA approves Janssen Biotech's STELARA for Crohn’s disease The US Food and Drug Administration (FDA) has approved Janssen Biotech's STELARA (ustekinumab) to treat moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.
Regulatory Affairs > News
FDA approves expanded use of Novartis’ Ilaris to treat three rare periodic fever syndromes By PBR Staff Writer
Novartis has secured three new approvals from the US Food and Drug Administration (FDA) for the expanded use of Ilaris (canakinumab) to treat three rare types of Periodic Fever Syndromes.
Regulatory Affairs > News Sanaria's preventative vaccine for malaria gets FDA fast track designation The US Food and Drug Administration (FDA) has granted Fast Track designation for Sanaria's preventative vaccine for malaria, Sanaria PfSPZ Vaccine.
Regulatory Affairs > News
See more Regulatory Affairs news

Latest Regulatory Affairs News and Insight

View all Regulatory Affairs news or find news targeted to your interests
FDA approves Janssen’s new type 2 diabetes combination therapy
By PBR Staff Writer
Janssen Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for a fixed-dose combination therapy to treat adults with type 2 diabetes.
Regulatory Affairs > News
FDA approves Sarepta Therapeutics' Duchenne muscular dystrophy drug
The US Food and Drug Administration (FDA) has granted accelerated approval for Sarepta Therapeutics' EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.
Regulatory Affairs > News
Cynata Therapeutics secures UK MHRA approval for GvHD clinical trial
Australian stem cell and regenerative medicine firm, Cynata Therapeutics, has secured approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to go ahead with its Phase 1 clinical trial of CYP-001 in patients with steroid-resistant graft-versus-host disease (GvHD).
Regulatory Affairs > News
Aralez's YOSPRALA gets FDA approval for secondary CV prevention
The US Food and Drug Administration (FDA) has approved Aralez Pharmaceuticals' once-daily YOSPRALA, the only prescription fixed-dose combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI) in the US.
Regulatory Affairs > News
Shire secures FDA approval for primary immunodeficiency drug
Shire has secured approval from the US Food and Drug Administration (FDA) for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older.
Regulatory Affairs > News
EC approves Cabometyx tablets to treat advanced RCC following VEGF-targeted therapy
By PBR Staff Writer
The European Commission (EC) has approved Cabometyx (cabozantinib) tablets to treat advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Regulatory Affairs > News
European Commission approves BMS' ORENCIA for methotrexate-naive RA patients
The European Commission has approved Bristol-Myers Squibb’s ORENCIA (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX.
Regulatory Affairs > News
FDA approves Amgen's BLINCYTO for pediatric acute lymphoblastic leukemia
The US Food and Drug Administration (FDA) has approved Amgen's supplemental Biologics License Application (sBLA) for BLINCYTO (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
US FDA calls for boxed warnings on two drug classes
The US Food and Drug Administration (FDA) is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system (CNS) depressant drugs called benzodiazepines.
Regulatory Affairs > News
Pfizer’s Xalkori gets European approval for ROS1-positive advanced NSCLC
By PBR Staff Writer
Pfizer has secured approval from the European Commission (EC) for Xalkori (crizotinib) to treat adults with ROS1-positive advanced non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
View all Regulatory Affairs news or find news targeted to your interests