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1-15 of 3321 results
FDA expands indication for Janssen Pharmaceuticals’ Invokamet diabetes drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expanded indication for Janssen Pharmaceuticals’ Invokamet diabetes medication.
Regulatory Affairs > News
European Commission approves Darzalex for multiple myeloma
By PBR Staff Writer
The European Commission has granted conditional approval to Darzalex (daratumumab) to treat adults with relapsed and refractory multiple myeloma.
Regulatory Affairs > News
European regulator accepts Pfizer's Trumenba marketing authorization application for review
The European Medicines Agency (EMA) has accepted Pfizer's marketing authorization application to review for Trumenba (Meningococcal Group B Vaccine), which was developed to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B (MnB) in individuals aged 10 years and above.
Regulatory Affairs > News
UK NICE rejects Roche’s Perjeta breast cancer drug
By PBR Staff Writer
UK’s National Institute for Health and Care Excellence (NICE) has rejected Roche’s Perjeta treatment for breast cancer claiming that it is pricey and would not offer value for money.
Regulatory Affairs > News
FDA approves Genentech's Atezolizumab for advanced urothelial carcinoma
By PBR Staff Writer
Genentech has secured approval from the US Food and Drug Administration for its Tecentriq (atezolizumab) to treat the most common type of bladder cancer, dubbed urothelial carcinoma.
Regulatory Affairs > News
EC grants marketing authorization for Actelion's Uptravi to treat pulmonary arterial hypertension
The European Commission (EC) has granted marketing authorization in the EU for Actelion's orally active, selective IP prostacyclin receptor agonist Uptravi (selexipag) to treat pulmonary arterial hypertension.
Regulatory Affairs > News
FDA approves Bristol-Myers Squibb's Opdivo for classical Hodgkin lymphoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted accelerated approval for Bristol-Myers Squibb's Opdivo (nivolumab) to treat patients with classical Hodgkin lymphoma (cHL).
Regulatory Affairs > News
FDA approves Eisai's Lenvima to treat advanced renal cell carcinoma in combination with Everolimus
The U.S. Food and Drug Administration (FDA) approved LENVIMA (lenvatinib), Eisai's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy.
Regulatory Affairs > News
European Commission approves Alprolix treat haemophilia B
Swedish Orphan Biovitrum AB and Biogen announced that the European Commission (EC) has approved Alprolix (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation.
Regulatory Affairs > News
European Commission approves Bristol-Myers Squibb's two new oncology treatments
By PBR Staff Writer
The European Commission (EC) has approved two new oncology treatments, one for advanced melanoma and the other for multiple myeloma.
Regulatory Affairs > News
FDA expands Imbruvica label to include survival data
By PBR Staff Writer
The US Food and Drug Administration (FDA) has expanded Imbruvica (ibrutinib) label to include overall survival (OS) data in previously untreated chronic lymphocytic leukemia.
Regulatory Affairs > News
FDA approves new formulation of Eisai’s Fycompa to treat seizure disorders
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Eisai’s Fycompa (perampanel) oral suspension as adjunctive therapy to treat partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures.
Regulatory Affairs > News
FDA approves Acadia's Nuplazid to treat Parkinson’s disease psychosis
By PBR Staff Writer
Acadia Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Parkinson’s disease psychosis.
Regulatory Affairs > News
Neovacs wins FDA approval to extend phase IIb clinical trial in Lupus to US
The US Food and Drug Administration (FDA) has approved Neovacs' investigational new drug application to extend its ongoing Phase IIb clinical trial of IFNα Kinoid to treat Lupus.
Regulatory Affairs > News
European Commission grants marketing authorisation to Lonsurf in mCRC
By PBR Staff Writer
The European Commission (EC) has granted marketing authorization for Taiho Pharmaceutical's Lonsurf (trifluridine/tipiracil), formerly known as TAS-102, to treat advanced metastatic colorectal cancer (mCRC).
Regulatory Affairs > News
1-15 of 3321 results