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151-165 of 3445 results
FDA grants orphan drug designation to ANAVEX 3-71 to treat Frontotemporal dementia
By PBR Staff Writer
Clinical-stage biopharmaceutical firm Anavex Life Sciences has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for ANAVEX 3-71 to treat Frontotemporal dementia (FTD).
Regulatory Affairs > News
European Commission approves Novartis' Revolade for children with chronic ITP
By PBR Staff Writer
Novartis has secured approval from the European Commission (EC) for Revolade (eltrombopag) to treat children with pediatric chronic immune thrombocytopenic purpura (ITP).
Regulatory Affairs > News
European Commission expands Opdivo approval for lung and kidney cancer
By PBR Staff Writer
The European Commission has approved new indications for Bristol-Myers Squibb's Opdivo (nivolumab) monotherapy, expanding its use in the treatment of non-small-cell lung cancer (NSCLC), and adding the indication of renal cell carcinoma (RCC).
Regulatory Affairs > News
FDA approves ANI Pharmaceuticals' Oxycodone HCl Capsules, 5mg
ANI Pharmaceuticals has received approval from the U.S. Food and Drug Administration (“FDA”) of the Abbreviated New Drug Application (“ANDA”) for Oxycodone HCl Capsules, 5mg.
Regulatory Affairs > News
FDA approves biosimilar of J&J's Remicade drug to treat autoimmune diseases
By PBR Staff Writer
Celltrion has secured approval from the US Food and Drug Administration (FDA) for its Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson's (J&J) Remicade drug used to treat autoimmune diseases.
Regulatory Affairs > News
FDA approves Jazz Pharmaceuticals' Defitelio to treat hepatic veno-occlusive disease
The US Food and Drug Administration (FDA) granted marketing approval for Jazz Pharmaceuticals' Defitelio (defibrotide sodium) for the treatment of adult and pediatric patients with hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following Hematopoietic Stem-Cell Transplantation (HSCT).
Regulatory Affairs > News
AstraZeneca secures Japanese approval for Tagrisso lung cancer treatment
AstraZeneca announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tagrisso (osimertinib, AZD9291) 80mg once-daily tablets for the treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy.
Regulatory Affairs > News
FDA rejects Brintellix label expansion for cognitive dysfunction
By PBR Staff Writer
The US Food and Drug Administration (FDA) has declined to add improved cognitive functions to Brintellix, an antidepressant used to treat major depressive disorder (MDD).
Regulatory Affairs > News
FDA rejects Eagle Pharma’s seven-year orphan drug exclusivity for Bendeka blood cancer drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) rejected Eagle Pharmaceuticals' request for seven years of orphan drug exclusivity for its blood cancer drug, Bendeka.
Regulatory Affairs > News
EC grants orphan drug status to Oxigene's CA4P to treat neuroendocrine tumors
By PBR Staff Writer
Oxigene has secured orphan drug designation from the European Commission (EC) for CA4P to treat gastro-entero-pancreatic neuroendocrine tumors (NETs).
Regulatory Affairs > News
FDA approves Teva's CINQAIR asthma injection
The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical Industries' CINQAIR (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
Regulatory Affairs > News
EMA accepts to review Pfizer's MAA for XELJANZ to treat moderate to severe rheumatoid arthritis
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for Pfizer's XELJANZ (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX).
Regulatory Affairs > News
Eli Lilly secures FDA approval for psoriasis drug Taltz
By PBR Staff Writer
Eli Lilly and Company has secured approval from the US Food and Drug Administration (FDA) for Taltz (ixekizumab) to treat moderate-to-severe plaque psoriasis in adults.
Regulatory Affairs > News
FDA approves Elusys' Anthim monoclonal antibody anthrax antitoxin
The US Food and Drug Administration (FDA) has approved ANTHIM (obiltoxaximab) Injection, Elusys Therapeutics' monoclonal antibody (mAb) anthrax antitoxin.
Regulatory Affairs > News
UK's NICE recommends Zytiga prostate cancer drug
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Janssen’s Zytiga (abiraterone) to treat advanced prostate cancer before chemotherapy.
Regulatory Affairs > News
151-165 of 3445 results