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U.S. FDA Approves Pfizer’s Biosimilar Nivestym

Pfizer Inc. announced that the U.S. FDA approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product.

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Agios Pharmaceuticals Scores FDA Approval For Tibsovo

The U.S. FDA approved Agios Pharmaceuticals’ oral leukemia treatment Tibsovo (ivosidenib).

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EU drug regulators step up work to prepare for ‘no deal’ Brexit

Drug regulators across Europe are hiring extra staff and increasing their workload as the role of British experts in the EU-wide system of medicines supervision winds down ahead of Brexit.

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Roche gets breakthrough status for Alzheimer’s test Elecsys

The U.S. Food and Drug Administration granted Roche an accelerated review for the Swiss drugmaker’s Elecsys product used to diagnose Alzheimer’s disease.

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FDA Launches Biosimilars Action Plan

The U.S. Food and Drug Administration released the regulatory agency’s Biosimilars Action Plan.

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FDA Approves Janssen’s Symtuza for HIV-1 Infection

The U.S. FDA approved Symtuza, the first complete darunavir-based single-tablet regimen for the treatment of human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults.

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FDA approves the first drug with an indication for treatment of smallpox

The U.S. FDA approved TPOXX (tecovirimat), the first drug with an indication for the treatment of smallpox.

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U.S. FDA Approves Xtandi for Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer

Astellas Pharma Inc. and Pfizer Inc. announced the U.S. FDA approved a supplemental New Drug Application for Xtandi (enzalutamide), following FDA Priority Review designation.

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FDA flags sale of recalled Kellogg’s Honey Smacks cereal

The U.S. Food and Drug Administration said recalled Kellogg Co. Honey Smacks cereal was still being sold at retail outlets and warned consumers not to purchase the product.

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Akcea and Ionis Announce EU Approval of Tegsedi

Akcea and Ionis’ Tegsedi (inotersen) received marketing authorization approval from the European Commission for treating stage 1 or stage 2 polyneuropathy in adults with hATTR.

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Bausch + Lomb Announces FDA Filing Acceptance

Bausch + Lomb announced the U.S. FDA accepted the New Drug Application for the company’s sub-micron loteprednol etabonate ophthalmic gel 0.38% with a PDUFA date of Feb. 25, 2019.

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Merz Snags FDA Approval for Chronic Sialorrhea

The FDA approved Merz Neurosciences’ supplemental Biologics License Application for Xeomin (incobotulinumtoxinA), a treatment for chronic drooling in adults with neurodegenerative diseases.

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Europe Approves Expanded Indication for Sprycel

The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.

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Health Canada Approves Erleada for nmCRPC

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada approved Erleada (apalutamide tablets), an oral treatment for patients with non-metastatic castration-resistant prostate cancer.

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FDA Withdraws Draft Guidance on Biosimilar Development

The U.S. Food and Drug Administration withdrew the regulatory agency’s draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.

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Alkermes Scores FDA Approval for Potential Game-Changing Schizophrenia Treatment

The U.S. FDA approved Alkermes plc’s Aristada Initio (aripiprazole lauroxil) as part of a combination treatment for schizophrenia.

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AstraZeneca wins speedy approvals for cancer drugs in Japan

AstraZeneca won rapid regulatory approval for new uses of two of the company’s important cancer drugs in Japan.

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Dermira wipe approved for excessive armpit sweating

The U.S. Food and Drug Administration approved Dermira Inc.’s topical cloth for excessive armpit sweating, providing patients with an easy-to-use option for an often embarrassing condition.

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Xeljanz Wins EU Approval for Active Psoriatic Arthritis

The European Commission approved Pfizer’s Xeljanz in combination with methotrexate for treating active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

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Array BioPharma gets FDA nod for melanoma combo treatment

The U.S. Food and Drug Administration approved Array BioPharma Inc.’s oral combination treatment for use in patients with the deadliest form of skin cancer.

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