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Regulatory Affairs

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 FDA approves Boehringer's Ofev to treat idiopathic pulmonary fibrosis By PBR Staff Writer
The US Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' Ofev (nintedanib) capsules to treat idiopathic pulmonary fibrosis (IPF).
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Genentech gets FDA approval for Esbriet to treat idiopathic pulmonary fibrosis
By PBR Staff Writer
Genentech, Roche's subsidiary, has received approval from US Food and Drug Administration (FDA) for Esbriet (pirfenidone) to treat patients with idiopathic pulmonary fibrosis (IPF).
Regulatory Affairs > News
FDA grants priority review designation for Eisai's Lenvatinib to treat advanced thyroid cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Eisai's new drug application (NDA) and has granted Priority Review status for its in-house developed agent lenvatinib mesylate (lenvatinib) to treat progressive radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC).
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ViiV Healthcare secures Canadian approval for Triumeq to treat HIV-1
By PBR Staff Writer
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer and Shionogi, has secured approval in Canada, for its Triumeq (dolutegravir 50mg, abacavir 600mg, and lamivudine 300mg) to treat patients with Human Immunodeficiency Virus (HIV-1) infection.
Regulatory Affairs > News
Orexo submits application to FDA for expanded label of ZUBSOLV
Orexo announces that it has submitted an application to the US Food and Drug Administration (FDA) for an expanded label of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) to include initiation of treatment for opioid dependence.
Regulatory Affairs > News
Nuvilex seeks FDA orphan drug designation for Cell-in-a-Box pancreatic cancer treatment
By PBR Staff Writer
US-based biotechnology firm Nuvilex has submitted an application to the US Food and Drug Administration (FDA) seeking orphan drug designation for its Cell-in-a-Box treatment for pancreatic cancer.
Regulatory Affairs > News
FDA grants approval for Akynzeo to treat chemotherapy-induced nausea, vomiting
By PBR Staff Writer
The US Food and Drug Administration has approved Akynzeo, a combination of netupitant and palonosetron, for the treatment of nausea and vomiting in patients undergoing cancer chemotherapy.
Regulatory Affairs > News
Gilead's Harvoni gets FDA approval for genotype 1 chronic hepatitis C treatment
By PBR Staff Writer
US-based biopharmaceutical firm Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for Harvoni (ledipasvir 90mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat chronic hepatitis C genotype 1 infection in adults.
Regulatory Affairs > News
FDA Approves Velcade for untreated mantle cell lymphoma
By PBR Staff Writer
The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved VELCADE® (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma (MCL).
Regulatory Affairs > News
US investigates Dr Reddy's and Sun Pharma over generic drugs price increases
By PBR Staff Writer
The US Congress has opened an investigation against the Indian pharma giants Dr Reddy's and Sun Pharma over price escalation of generic drugs.
Regulatory Affairs > News
Salix's ulcerative colitis treatment UCERIS gets FDA approval
By PBR Staff Writer
Salix Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for UCERIS (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge.
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