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76-90 of 3532 results
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
FDA approves Teva’s austedo to treat chorea in HD patients
By PBR Staff Writer
Teva Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for austedo (deutetrabenazine) tablets to treat chorea associated with Huntington’s disease (HD).
Regulatory Affairs > News
EU approves Novartis Tafinlar + Mekinist combination for NSCLC treatment
Novartis’ drug combination of Tafinlar (dabrafenib) and Mekinist (trametinib) has been approved by the European Commission for the treatment of patients having BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA approves AstraZeneca’s Tagrisso to treat mutation-positive NSCLC
By PBR Staff Writer
AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its Tagrisso (osimertinib) 80mg once-daily tablets to treat patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA approves Roche’s Ocrevus for relapsing and primary progressive MS
By PBR Staff Writer
Roche has secured approval from the US Food and Drug Administration (FDA) for its Ocrevus (ocrelizumab) to treat patients with relapsing and primary progressive forms of multiple sclerosis (MS).
Regulatory Affairs > News
Genentech's Rituxan gets FDA breakthrough therapy status to treat pemphigus vulgaris
By PBR Staff Writer
Roche’s subsidiary Genentech has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Rituxan (rituximab) to treat pemphigus vulgaris.
Regulatory Affairs > News
Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases
Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.
Regulatory Affairs > News
Merck, Pfizer get FDA nod for Bavencio to treat metastatic Merkel cell carcinoma
By PBR Staff Writer
Merck’s EMD Serono and Pfizer have secured approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) injection 20 mg/mL to treat metastatic Merkel cell carcinoma (mMCC).
Regulatory Affairs > News
76-90 of 3532 results