Regulatory Affairs

Regulatory Affairs News

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Valeant gets FDA approval for SILIQ to treat moderate-to-severe plaque psoriasis
The US Food and Drug Administration (FDA) has approved Valeant Pharmaceuticals International's Biologics License Application (BLA) for SILIQ (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis.
Regulatory Affairs > News
Marathon Pharmaceuticals’ Duchenne muscular dystrophy drug wins FDA approval
By PBR Staff Writer
Marathon Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Emflaza (deflazacort) to treat Duchenne muscular dystrophy in patients 5 years and older.
Regulatory Affairs > News
Amgen secures FDA approval for Parsabiv drug to treat chronic kidney disease
By PBR Staff Writer
Amgen has secured approval from the US Food and Drug Administration (FDA) for Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) undergoing hemodialysis.
Regulatory Affairs > News
Sobi secures European Commission approval for new dosing frequency of Orfadin
The European Commission (EC) has approved a reduced dosing frequency for Swedish Orphan Biovitrum International's (Sobi) Orfadin (nitisinone) from twice daily to once daily, in people with hereditary tyrosinemia type 1 (HT-1) with a body weight >20 kg.
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FDA approves Sanofi's Xyzal Allergy 24HR for OTC use
By PBR Staff Writer
Sanofi has secured approval from the US Food and Drug Administration (FDA) for its 24-hour formulation of levocetirizine dihydrochloride (Xyzal Allergy 24HR) for the over-the-counter (OTC) treatment of symptoms associated with seasonal and year-round allergies.
Regulatory Affairs > News
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.
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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.
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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.
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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).
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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).
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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
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