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61-75 of 3445 results
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
FDA approves Sandoz’s Enbrel biosimilar for multiple inflammatory diseases
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Sandoz’s Erelzi, a biosimilar to Amgen's Enbrel, to treat several inflammatory diseases.
Regulatory Affairs > News
Perrigo secures tentative FDA approval for generic version of Suprep oral solution
Perrigo has received tentative approval from the U.S. Food and Drug Administration (FDA) for the generic version of Suprep (sodium sulfate/potassium sulfate/magnesium sulfate) oral solution.
Regulatory Affairs > News
AstraZeneca and Eli Lilly secure FDA fast-track status for Alzheimer’s drug
By PBR Staff Writer
AstraZeneca and Eli Lilly and Company have secured fast track designation from the US Food and Drug Administration (FDA) for AZD3293, an investigational treatment for early Alzheimer’s disease (AD).
Regulatory Affairs > News
EC grants marketing authorization for Gilead’s once-daily truvada to reduce risk of sexually acquired HIV-1
The European Commission has granted marketing authorization for Gilead Sciences' once-daily Truvada (emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP.
Regulatory Affairs > News
FDA approves Pfizer's Troxyca ER extended-release capsules for pain management
By PBR Staff Writer
Pfizer has secured approval from the US Food and Drug Administration (FDA) for Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules CII with abuse-deterrent properties for the management of pain.
Regulatory Affairs > News
61-75 of 3445 results