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31-45 of 3494 results
Genentech’s Actemra approved by FDA for giant cell arteritis treatment
Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.
Regulatory Affairs > News
EC launches probe into Aspen's pricing practices for cancer drugs
The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.
Regulatory Affairs > News
FDA turns down generic version of GSK's asthma/COPD inhaler Advair Diskus
By PBR Staff Writer
Vectura and its partner Hikma Pharmaceuticals announced that the US Food and Drug Administration (FDA) turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus.
Regulatory Affairs > News
FDA approves Novartis’ Rydapt for AML and rare blood disorders
By PBR Staff Writer
Novartis’ Rydapt (midostaurin) has secured approval from the US Food and Drug Administration (FDA) in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM).
Regulatory Affairs > News
Shire wins EC conditional approval for Natpar to treat hypoparathyroidism
By PBR Staff Writer
Shire has secured conditional marketing approval from the European Commission (EC) for its Natpar (rhPTH[1-84]) to treat patients with chronic hypoparathyroidism.
Regulatory Affairs > News
EC approves AstraZeneca’s Tagrisso to treat mutation-positive NSCLC
By PBR Staff Writer
AstraZeneca has secured full marketing authorization from the European Commission (EC) for its Tagrisso (osimertinib) 40mg and 80mg once-daily tablets to treat adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA rejects Vernalis’ NDA for cough cold treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Vernalis’ new drug application for cough cold treatment, CCP-07.
Regulatory Affairs > News
Genentech’s ranibizumab injection approved by FDA for diabetic retinopathy
The US Food and Drug Administration (FDA) has approved Genentech’s Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy.
Regulatory Affairs > News
FDA reject’s Eli Lilly’s NDA for rheumatoid arthritis drug baricitinib
By PBR Staff Writer
The US Food and Drug Administration has rejected Eli Lilly and Incyte’s new drug application (NDA) for investigational medicine baricitinib to treat moderate-to-severe rheumatoid arthritis (RA).
Regulatory Affairs > News
FDA approves Neurocrine’s Ingrezza to treat tardive dyskinesia
By PBR Staff Writer
Neurocrine Biosciences has secured approval from the US Food and Drug Administration (FDA) for its Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia (TD).
Regulatory Affairs > News
Scotland approves new drugs for HIV, cancer and others
By PBR Staff Writer
The Scottish Medicines Consortium (SMC) has approved five new treatments for breast cancer, multiple sclerosis, leukaemia and others.
Regulatory Affairs > News
FDA approves supplemental applications of two hepatitis C drugs for pediatric patients
Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for supplemental indications of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) tablets and Sovaldi (sofosbuvir 400 mg) tablets for chronic hepatitis C virus (HCV) infection treatment in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg.
Regulatory Affairs > News
FDA rejects Merck's application to add heart data to labelling for diabetes drugs
By PBR Staff Writer
Merck has received a complete response letter from the US Food and Drug Administration (FDA) seeking to add cardiovascular outcomes data from the TECOS study to the labels of J Januvia (sitagliptin), Janumet (sitagliptin and metformin), and Janumet XR (sitagliptin and metformin extended-release).
Regulatory Affairs > News
Regeneron’s evinacumab gets FDA breakthrough therapy status to treat HoFH
By PBR Staff Writer
Regeneron Pharmaceuticals has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its evinacumab to treat patients with homozygous familial hypercholesterolemia (HoFH).
Regulatory Affairs > News
FDA accepts to review AbbVie’s sNDA for ibrutinib in cGVHD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for review AbbVie's supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
Regulatory Affairs > News
31-45 of 3494 results