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Regulatory Affairs

FDA grants priority review to Pfizer's antibody-drug conjugate for ALL By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted a priority review designation to Pfizer's anti-CD22 antibody-drug conjugate inotuzumab ozogamicin to treat patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
European Commission conditionally approves Roche’s cancer drug Alecensa By PBR Staff Writer
Roche's oral ALK inhibitor, Alecensa, has been conditionally approved in the European Union as a monotherapy for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC) in adults who were earlier treated with crizotinib.
Regulatory Affairs > News 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
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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
NSF International and IDMA Offer Pharmaceutical Quality Management Education in Bangalore
Advanced Program in Pharmaceutical Quality Management leads to an international certification in pharmaceutical GMP compliance from NSF International and Indian Drug Manufacturers’ Association
Regulatory Affairs > Press Releases
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.
Regulatory Affairs > News
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.
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
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