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1-15 of 3374 results
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
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
1-15 of 3374 results