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16-30 of 3526 results
Pfizer gets FDA nod for acute myeloid leukaemia drug Mylotarg
By PBR Staff Writer
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Mylotarg (gemtuzumab ozogamicin) to treat adults with newly diagnosed CD33-positive acute myeloid leukemia (AML).
Regulatory Affairs > News
Bayer submits BLA to FDA for BAY94-9027 to treat Hemophilia A
By PBR Staff Writer
Bayer is seeking approval from the US Food and Drug Administration (FDA) for its its long-acting factor VIII, BAY94-9027, to treat Hemophilia A.
Regulatory Affairs > News
Novartis gets FDA nod for cancer treatment Kymriah
By PBR Staff Writer
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel or CTL019) to treat children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
European Commission grants approval for Mavenclad
Merck announced that the European Commission (EC) has granted marketing authorization for Mavenclad 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis*(RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
Regulatory Affairs > News
Samsung Bioepis’ Humira biosimilar Imraldi approved in Europe
By EBR Staff Writer
Samsung Bioepis' Imraldi, the anti-TNF biosimilar of Humira (adalimumab), has been approved by the European Commission (EC) for all indications of the AbbVie monoclonal antibody.
Regulatory Affairs > News
European Commission approves Novartis breast cancer drug Kisqali
Novartis’ breast cancer drug Kisqal has secured authorisation from the European Commission for the treatment of advanced breast cancer.
Regulatory Affairs > News
Epygenix gets FDA orphan drug status for EPX-300 to treat Dravet Syndrome
Epygenix Therapeutics has secured orphan drug status from the US Food and Drug Administration (FDA) for its EPX-300 to treat patients with Dravet Syndrome.
Regulatory Affairs > News
EC grants new indication for Soliris to treat refractory generalized myasthenia gravis
Alexion Pharmaceuticals announced that the European Commission (EC) approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
Regulatory Affairs > News
Ironwood’s Duzallo gets FDA approval for gout-associated hyperuricemia
By PBR Staff Writer
Ironwood Pharmaceuticals’ Duzallo has been approved by the US Food and Drug Administration (FDA) for the treatment of hyperuricemia in patients with uncontrolled gout.
Regulatory Affairs > News
AstraZeneca, Merck get FDA approval for expanded use of ovarian cancer drug
By PBR Staff Writer
AstraZeneca and Merck have secured approvals from The US Food and Drug Administration (FDA) to expand the indication for their newly formulated Lynparza to cover a broader group of women suffering from ovarian cancer.
Regulatory Affairs > News
Pfizer gets FDA nod for blood cancer treatment Besponsa
By PBR Staff Writer
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Besponsa (inotuzumab ozogamicin) to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
FDA lifts clinical hold on study of Multikine for head and neck cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has lifted the clinical hold it had imposed on the CEL-SCI and Ergomed co-developed Multikine’s phase 3 head and neck cancer study.
Regulatory Affairs > News
PharmaTech liquid drugs recalled in US over bacterial contamination
By PBR Staff Writer
The US Food and Drug Administration (FDA) has issued an advisory against consumption of all liquid products manufactured by PharmaTech over concerns of possible contamination with a bacteria called Burkholderia cepacia (B. cepacia).
Regulatory Affairs > News
Clinigen gets EC nod to update product information for Cardioxane
Clinigen Group has secured approval from the European Commission (EC) to update the current product information for Cardioxane.
Regulatory Affairs > News
AbbVie’s Mavyret secures FDA approval for chronic hepatitis C treatment
The US Food and Drug Administration (FDA) has approved AbbVie's Mavyret (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment has been approved by for treating adult patients with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).
Regulatory Affairs > News
16-30 of 3526 results