Regulatory Affairs

Regulatory Affairs News

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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
Pfizer, Servier get FDA nod to start US testing of UCART19
By PBR Staff Writer
Servier and Pfizer have secured clearance from the US Food and Drug Administration (FDA) to go ahead with the clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia.
Regulatory Affairs > News
EC approves Actelion's topical chlormethine gel to treat MF-Type CTCL
By PBR Staff Writer
Actelion has secured marketing authorization from the European Commission (EC) for its Ledaga (chlormethine gel) 160 micrograms/g to treat mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).
Regulatory Affairs > News
Actavis UK and Concordia accused of fixing price of life-saving drug
By PBR Staff Writer
Pharmaceutical companies Concordia International and Actavis UK have been alleged of illegally colluding to keep prices of hydrocortisone tablets high in the UK.
Regulatory Affairs > News
UK's NICE backs use of Intercept's Ocaliva for primary biliary cholangitis
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) has been approved by the UK's National Institute for Health and Care Excellence (NICE) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland.
Regulatory Affairs > News
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
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