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16-30 of 3467 results
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
Akashi gets FDA nod to restart clinical development of DMD drug HT-100
Akashi Therapeutics has secured approval from the US Food and Drug Administration (FDA) to resume clinical development of HT-100 (delayed-release halofuginone) in patients with any of the genetic mutations that cause Duchenne muscular dystrophy (DMD).
Regulatory Affairs > News
Newron’s Xadago gets FDA nod to treat Parkinson’s disease
By PBR Staff Writer
Newron Pharmaceuticals, along with its partners Zambon and US WorldMeds, has secured approval from the US the Food and Drug Administration (FDA) for its Xadago (safinamide) to treat patients with Parkinson’s disease (PD).
Regulatory Affairs > News
Shire’s HAE drug Cinryze secures label extension in Europe
By PBR Staff Writer
Shire has secured label expansion approval from the European Commission for its hereditary angioedema therapy Cinryze.
Regulatory Affairs > News
FDA approves Merck's Keytruda for Hodgkin lymphoma
By PBR Staff Writer
Merck has secured another approval from the US Food and Drug Administration (FDA) for Keytruda, this time for classical Hodgkin lymphoma.
Regulatory Affairs > News
FDA approves Novartis’ Kisqali to treat metastatic breast cancer
By PBR Staff Writer
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Kisqali (ribociclib or LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy to treat metastatic breast cancer.
Regulatory Affairs > News
16-30 of 3467 results