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76-90 of 3501 results
EU approves Novartis’ Votubia to treat seizures in TSC patients
By PBR Staff Writer
The European Commission (EC) has expanded the approved uses of Novartis' drug Votubia (everolimus) to include treatment for refractory partial-onset seizures in patients with tuberous sclerosis complex (TSC).
Regulatory Affairs > News
FDA approves label update to Allergan's Avycaz
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Allergan’s supplemental New Drug Application (sNDA)for Avycaz to include new phase III data in patients with complicated urinary tract infections (cUTI), including Pyelonephritis.
Regulatory Affairs > News
FDA approves 72 mcg dose of LINZESS for adults with chronic idiopathic constipation
The US Food and Drug Administration (FDA) has approved a 72 mcg dose of Ironwood Pharmaceuticals' LINZESS(linaclotide) for the treatment of chronic idiopathic constipation (CIC) in adult patients.
Regulatory Affairs > News
FDA approves Imbruvica for relapsed/refractory marginal zone lymphoma
The US Food and Drug Administration (FDA) has granted an accelerated approval to Imbruvica (ibrutinib) as first treatment specifically indicated for relapsed/refractory marginal zone lymphoma (MZL), a rare type of Non-Hodgkin's Lymphoma.
Regulatory Affairs > News
European Commission approves Suliqua to treat adults with type 2 diabetes
Sanofi has secured approval from the European Commission for Suliqua, the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
Regulatory Affairs > News
Scottish Medicines Consortium approves Zepatier to treat chronic hepatitis C
By PBR Staff Writer
A new medicine intended to treat chronic hepatitis C is one of four accepted by the Scottish Medicines Consortium (SMC) for routine use in NHS Scotland.
Regulatory Affairs > News
Gilead gets European approval for hepatitis B drug Vemlidy
Gilead Sciences has received marketing authorization from the European Commission for Vemlidy (tenofovir alafenamide, TAF) 25 mg, a once-daily tablet for chronic hepatitis B virus (HBV) infection treatment in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
Regulatory Affairs > News
FDA grants orphan drug status for Sangamo’s SB-318 genome editing treatment for MPS I
Sangamo Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its genome editing product candidate, SB-318, to treat Mucopolysaccharidosis Type I (MPS I).
Regulatory Affairs > News
FDA approves Egalet’s opioid prescription painkiller
By PBR Staff Writer
Egalet has secured approval from the US Food and Drug Administration (FDA) for Arymo ER (morphine sulfate) C-II, an extended-release morphine product formulated with abuse-deterrent properties for treatment of chronic pain.
Regulatory Affairs > News
Genentech’s Lucentis gets FDA approval for myopic choroidal neovascularization
Genentech’s Lucentis (ranibizumab injection) 0.5 mg has been approved by the US Food and Drug Administration (FDA) for the treatment of patients with myopic choroidal neovascularization (mCNV).
Regulatory Affairs > News
FDA grants orphan drug designation for Marinus' ganaxolone to treat FXS
By PBR Staff Writer
Marinus Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for its CNS-selective GABAA modulator, ganaxolone, to treat Fragile X Syndrome (FXS).
Regulatory Affairs > News
Innocoll receives refusal to file letter from FDA for post-surgical pain candidate
By PBR Staff Writer
The US Food and Drug Administration (FDA) has issued a Refuse-to-File letter halting further review of Innocoll's new drug application (NDA) for its post-surgical pain candidate Xaracoll.
Regulatory Affairs > News
Novo Nordisk gets FDA approval for Tresiba's use in children
Novo Nordisk secured approval from the US Food and Drug Administration (FDA) for an expanded use for Tresiba (insulin degludec) injection to improve glycemic control in children and adolescents with both type 1 and type 2 diabetes.
Regulatory Affairs > News
Pfizer announces EC approval for Nimenrix in infants six weeks of age and older
Pfizer has secured approval from the European Commission (EC) for an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age.
Regulatory Affairs > News
FDA drops boxed warning on Pfizer's smoking cessation drug
The U.S. Food and Drug Administration (FDA) has approved updates to Pfizer’s CHANTIX (varenicline) labeling, including removal of the boxed warning regarding serious neuropsychiatric events.
Regulatory Affairs > News
76-90 of 3501 results