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Novartis wins FDA’s breakthrough tag for lung cancer hopeful

Novartis secured U.S. FDA Breakthrough Therapy Designation for the investigational medicine capmatinib, which the company aims to file for approval during 2019 against a mutated form of lung cancer.

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Calquence Earns Breakthrough Therapy Designation

AstraZeneca’s BTK inhibitor Calquence won Breakthrough Therapy Designation from the U.S. FDA as a monotherapy treatment for patients with chronic lymphocytic leukemia (CLL).

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Pfizer gets U.S. approval for $225,000 a year heart drug

The U.S. Food and Drug Administration approved Pfizer Inc.’s oral drug tafamidis to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy.

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FDA Grants Breakthrough Therapy Designation to Genfit’s Elafibranor for Treatment of PBC

Genfit’s elafibranor was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Primary Biliary Cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid.

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Johnson & Johnson wins U.S. FDA approval for bladder cancer drug

Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.

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PhaseBio Receives FDA Breakthrough Therapy Designation and Licenses GLP-1 Analog to ImmunoForge

PhaseBio Pharmaceuticals’ antiplatelet drug PB2452 received Breakthrough Therapy designation from the U.S. FDA.

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Top 10 Pipelines To Watch: 2019 Annual Report

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

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Novartis’ crizanlizumab receives FDA Breakthrough Therapy designation for prevention of vaso-occlusive crises in sickle cell disease

Novartis announced that the U.S. Food and Drug Administration granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises in patients of all genotypes with sickle cell disease.

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Novartis’ blood disorder drug gets FDA approval for expanded use

The U.S. Food and Drug Administration expanded the use of Novartis AG’s low platelets drug Promacta to treat patients with a rare, genetic blood disorder.

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FDA Grants Breakthrough Therapy Designation for Concentric Analgesics’ CA-008 in Post-Surgical Pain

Concentric Analgesics Inc. announced today that the clinical-stage biopharmaceutical company received Breakthrough Therapy designation from the U.S. Food and Drug Administration for CA-008 in post-surgical pain.

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