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Regulatory Affairs

DCGI gives limited approval to market first Allogeneic cell therapy product in India The Drugs Controller General (India) has granted limited approval for manufacturing & marketing of stem cell based biological product Stempeucel for the treatment of Buerger's Disease.
Regulatory Affairs > News
European Commission approves Samsung Bioepis’ Remicade biosimilar By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Flixabi, a biosimilar version of Johnson & Johnson's Remicade (infliximab) rheumatoid arthritis drug.
Regulatory Affairs > News European Commission approves Strimvelis to treat immune deficiency disorder in children By PBR Staff Writer
The European Commission (EC) has approved Strimvelis, an ex-vivo stem cell gene therapy for the treatment of a very rare disorder called ADA-SCID, or severe combined immunodeficiency due to adenosine deaminase deficiency.
Regulatory Affairs > News
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FDA approves Zinbryta to treat relapsing forms of multiple sclerosis
By PBR Staff Writer
Biogen and AbbVie have secured approval from the US Food and Drug Administration for Zinbryta (daclizumab) to treat adults with relapsing forms of multiple sclerosis (MS).
Regulatory Affairs > News
Titan Pharmaceuticals wins FDA approval for Probuphine to treat opioid dependence
The US Food and Drug Administration has approved Titan Pharmaceuticals' Probuphine (buprenorphine) implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.
Regulatory Affairs > News
FDA approves CSL Behring's single-chain Afstyla for hemophilia A
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved CSL Behring's Afstyla [Antihemophilic Factor (Recombinant) Single Chain] to treat adults and children with hemophilia A.
Regulatory Affairs > News
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
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