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76-90 of 3445 results
Teva secures European approval for severe asthma drug Cinqaero
Teva Pharmaceutical Industries has secured marketing authorization from the European Commission for Cinqaero (reslizumab) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
Regulatory Affairs > News
Acacia Pharma unveils positive results from phase 3 trial of BAREMSIS to treat PONV
Acacia Pharma has unveiled positive results from a pivotal Phase 3 study investigating BAREMSIS (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (PONV).
Regulatory Affairs > News
FDA approves Heron’s Sustol for chemotherapy-induced nausea and vomiting
By PBR Staff Writer
Heron Therapeutics has secured approval from the US Food and Drug Administration (FDA) for extended-release version of the chemotherapy anti-nausea drug Sustol (granisetron).
Regulatory Affairs > News
Moberg Pharma gets approvals to begin phase 3 trial for MOB-015 in US and Canada
By PBR Staff Writer
Moberg Pharma has secured approvals from the US and Canadian regulators to start phase 3 trial for MOB-015 in the treatment of onychomycosis (nail fungus).
Regulatory Affairs > News
EMA approves single dose administration of Cardiome Pharma's XYDALBA
The European Medicines Agency (EMA) has approved Cardiome Pharma's XYDALBA (dalbavancin) for administration as a single, 30 minute, 1500mg infusion (three 500mg vials).
Regulatory Affairs > News
EU clears Sanofi’s acquisition of Boehringer’s consumer health business
By PBR Staff Writer
French drug maker Sanofi has secured approval from the European Commission for its proposed acquisition of Boehringer Ingelheim’s consumer health business, subject to conditions.
Regulatory Affairs > News
Dynavax announces FDA advisory committee meeting to review HEPLISAV-B BLA
Dynavax Technologies announced that the Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016.
Regulatory Affairs > News
Merck’s Keytruda secures European approval for advanced NSCLC
By PBR Staff Writer
Merck has secured approval from the European Commission for its Keytruda (pembrolizumab) anti-PD-1 therapy to treat patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer (NSCLC) following at least 1 chemotherapy regimen.
Regulatory Affairs > News
Novartis' LEE011 breast cancer drug gets US breakthrough therapy designation
By PBR Staff Writer
Novartis' selective cyclin dependent kinase inhibitor LEE011 (ribociclib) has secured breakthrough therapy designation in the US to treat certain forms of breast cancer.
Regulatory Affairs > News
FDA accepts Neon Therapeutics' IND for cancer vaccine NEO-PV-01
The US Food and Drug Administration (FDA) has accepted Neon Therapeutics' Investigational New Drug (IND) application for its lead program, NEO-PV-01.
Regulatory Affairs > News
European Commission approves Merck’s Zepatier hepatitis C drug
By PBR Staff Writer
The European Commission has approved US pharma giant Merck & Co’s Zepatier (elbasvir/grazoprevir) with or without ribavirin (RBV) to treat chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection in adults.
Regulatory Affairs > News
Oxford BioMedica secures UK MHRA approval to manufacture drugs at new facilities
By PBR Staff Writer
Oxford BioMedica has secured approvals from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for investigational medicinal products at its new facilities.
Regulatory Affairs > News
Sanofi wins FDA approval of Adlyxin to treat adults with type 2 diabetes
Sanofi announced that the US Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.
Regulatory Affairs > News
US FTC approves Teva’s $40.5bn deal for Allergan’s generics business
By PBR Staff Writer
The US Federal Trade Commission (FTC) has approved Teva Pharmaceutical Industries’ proposed $40.5bn acquisition of Allergan’s generics business.
Regulatory Affairs > News
FDA lifts clinical hold on CGF166
GenVec, a clinical-stage gene delivery company, was notified by its collaborator, Novartis, that the Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 1/2 clinical trial of CGF166 in patients with severe to profound hearing loss.
Regulatory Affairs > News
76-90 of 3445 results