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136-150 of 3501 results
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
FDA raises concerns over manufacturing practice of Valeant’s new ophthalmic solution
By PBR Staff Writer
The US Food and Drug Administration has raised concerns over manufacturing practice of Valeant Pharmaceuticals International’s new eye drop.
Regulatory Affairs > News
European CHMP recommends Shire’s Onivyde to treat metastatic adenocarcinoma
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Shire’s Onivyde (irinotecan pegylated liposomal formulation) to treat metastatic adenocarcinoma.
Regulatory Affairs > News
European CHMP adopts positive opinion on Gilead’s Type II variation application for Truvada
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' Type II variation application for Truvada for reducing the risk of sexually acquired HIV.
Regulatory Affairs > News
FDA approves Relistor tablets to treat OIC in chronic non-cancer pain adults
By PBR Staff Writer
The US Food and Drug Administration has approved Relistor (methylnaltrexone bromide) tablets to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Regulatory Affairs > News
136-150 of 3501 results