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 | News
Search Refinements

Regulatory Affairs News

View news from other Pharmaceutical sectors:
136-150 of 3478 results
UK’s NICE approves Pfizer’s Bosulif for chronic myeloid leukaemia
By PBR Staff Writer
The UK’s National Institute for Health and Care Excellence (NICE) has approved Pfizer’s Bosulif (bosutinib) to treat some people with chronic myeloid leukaemia (CML).
Regulatory Affairs > News
Shire gets extension of market authorization in Europe for Revestive to treat paediatric patients with SBS
The European Commission has granted extension of Market Authorization for Shire's Revestive (teduglutide) 5 mg powder and solvent for solution for injection for the treatment of patients aged one year and above with Short Bowel Syndrome (SBS).
Regulatory Affairs > News
EC approves Adcetris as consolidation treatment in post-transplant hodgkin lymphoma
By PBR Staff Writer
The European Commission (EC) has approved Adcetris (brentuximab vedotin) for use as a consolidation therapy to treat adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT).
Regulatory Affairs > News
European Commission approves Zinbryta to treat relapsing forms of multiple sclerosis
The European Commission (EC) has approved Zinbryta (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).
Regulatory Affairs > News
EC approves extended indication for Amgen's Kyprolis to treat relapsed multiple myeloma
By PBR Staff Writer
The European Commission (EC) has approved extended indication for Amgen's Kyprolis (Carfilzomib) to treat patients with relapsed multiple myeloma.
Regulatory Affairs > News
EC grants orphan drug status to Mereo's BPS-804 for osteogenesis imperfecta
By PBR Staff Writer
Mereo BioPharma Group announced that its drug BPS-804 has been granted orphan drug designation by the European Commission (EC) in the treatment of osteogenesis imperfecta (OI).
Regulatory Affairs > News
FDA declines to approve Lipocine’s LPCN 1021 testosterone drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) has declined to approve Lipocine’s LPCN 1021 testosterone drug.
Regulatory Affairs > News
Gilead Sciences’ Epclusa gets FDA approval to treat chronic Hepatitis C virus infection
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Epclusa to treat adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.
Regulatory Affairs > News
Sobi's Elocta approved in Switzerland to treat haemophilia A
Swedish Orphan Biovitrum AB announced that the Swiss Agency for Therapeutic Products, Swissmedic, has approved Elocta (rFVIIIFc) for the treatment of haemophilia A.
Regulatory Affairs > News
Perrigo secures FDA approval for generic version of Ofirmev acetaminophen injection
Perrigo has received final US Food and Drug Administration (FDA) approval for the generic version of Mallinckrodt Pharmaceuticals' Ofirmev (acetaminophen) injection 1000 mg/100 mL.
Regulatory Affairs > News
FDA approves expanded label for emphysema treatment Glassia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expanded label for self-infusion of Glassia to treat emphysema due to serious Alpha-1 Antitrypsin (AAT) deficiency.
Regulatory Affairs > News
FDA approves higher dosage strength Orfadin capsule for HT-1 treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a higher strength 20mg capsule of Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinosne) to treat Hereditary Tyrosinaemia type-1 (HT-1).
Regulatory Affairs > News
FDA approves Espero Pharmaceuticals’ Gonitro sublingual powder for angina
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Espero Pharmaceuticals’ Gonitro (nitroglycerin) sublingual powder, which is indicated to provide acute relief for an attack of angina pectoris due to coronary artery disease.
Regulatory Affairs > News
ViiV Healthcare wins FDA approval to lower weight limit for dolutegravir HIV drug in children and adolescents
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s supplemental new drug application to reduce the weight limit for dolutegravir to treat HIV-1 in children and adolescents.
Regulatory Affairs > News
Novartis' Afinitor drug secures EU approval for GI, lung neuroendocrine tumors
By PBR Staff Writer
The European Commission has approved Novartis' Afinitor drug to treat various types of advanced gastrointestinal (GI) and lung neuroendocrine tumors (NET).
Regulatory Affairs > News
136-150 of 3478 results