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Regulatory Affairs

RetroSense gets FDA orphan drug status for RST-001 to treat retinitis pigmentosa By PBR Staff Writer
US-based RetroSense Therapeutics has received orphan drug designation from the Food and Drug Administration (FDA) for its lead product RST-001 to treat retinitis pigmentosa (RP), a genetic condition which leads to the progressive degeneration of rod and cone photoreceptors.
Regulatory Affairs > News
FDA grants accelerated approval for Pfizer' meningococcal B vaccine Trumenba By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted accelerated approval for Pfizer's Trumenba (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25 years.
Regulatory Affairs > News FDA grants breakthrough therapy status for Merck's lung cancer drug Keytruda By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Merck's anti-PD-1 therapy Keytruda (pembrolizumab) to treat patients with advanced non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
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Mundipharma's Targin receives CHMP positive opinion to treat restless legs syndrome
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Mundipharma's Targin as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome (RLS).
Regulatory Affairs > News
Baxter's Obizur gets FDA approval to treat adults with acquired hemophilia A
By PBR Staff Writer
Baxter International has received approval from the US Food and Drug Administration (FDA) for Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] to treat bleeding episodes in adults with acquired hemophilia A (AHA).
Regulatory Affairs > News
EMA committee recommends AstraZeneca's ovarian cancer drug Lynparza
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending AstraZeneca's marketing authorization of ovarian cancer drug Lynparza (olaparib) as monotherapy.
Regulatory Affairs > News
NICE recommends Bayer's rivaroxaban as option for secondary prevention in ACS
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued its Appraisal Consultation Document (ACD) recommending Bayer HealthCare's Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome (ACS).
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EMA grants orphan status for GW Pharmaceuticals' Epidiolex to treat Dravet syndrome
By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan designation to GW Pharmaceuticals' investigational product Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
Regulatory Affairs > News
NICE recommends GSK's skin cancer drug Tafinlar
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending GlaxoSmithKline's (GSK) Tafinlar (dabrafenib) to treat certain NHS patients with melanoma, a type of skin cancer.
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FDA approves Auxilium's Xiaflex to treat Dupuytren's Contracture
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for Auxilium Pharmaceuticals' Xiaflex (collagenase clostridium histolyticum or CCH) to treat up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.
Regulatory Affairs > News
Novartis' plaque psoriasis drug candidate AIN457 gets FDA committee recommendation
By PBR Staff Writer
The US Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has approved Novartis' AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, to treat moderate-to-severe plaque psoriasis in adult patients.
Regulatory Affairs > News
Pharmacyclics' Imbruvica gets European approval to treat two blood cancers
By PBR Staff Writer
The European Commission (EC) has granted marketing approval for Pharmacyclics' Imbruvica (ibrutinib), a first-in-class, oral, once-daily, non-chemotherapy treatment for patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL).
Regulatory Affairs > News
Health Canada issues notice of compliance for Gilead hepatitis C drug Harvoni
By PBR Staff Writer
Health Canada has issued a Notice of Compliance for Gilead Sciences' Harvoni (ledipasvir 90 mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat chronic hepatitis C genotype 1 infection in adults.
Regulatory Affairs > News
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