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FDA Head Postpones Layoff Notices of Thousands of Employees

FDA’s commissioner told staff in an email that he intends to delay any labor reductions until the end of September unless Congress authorizes its user fee program to provide the necessary funding.

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FDA Green Lights Gilead’s Vosevi; Black-Box Warning Attached

The FDA approved Gilead Sciences’ Vosevi, an oral medicine for the re-treatment of chronic HCV.

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Puma Biotech Surges After the FDA Officially Approves Breast Cancer Drug

The FDA approved Puma Biotechnology’s breast cancer drug Nerlynx (neratinib).

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FDA Gives Nod to J&J’s Tremfya

FDA approved Janssen Biotech’s Tremfya (guselkumab) for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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Korea Approves the World’s First Cell and Gene Therapy for Knee Osteoarthritis

The Korea Ministry of Food and Drug Safety granted marketing approval for Invossa-K Inj., the world’s first cell and gene therapy for degenerative arthritis.

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FDA approves new treatment for sickle cell disease

FDA approved Endari oral powder for patients 5 years and older with sickle cell disease to reduce severe complications associated with the blood disorder.

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Novartis receives EU approval for Cosentyx label update

Novartis said the Committee for Medicinal Products for Human Use approved a label update for Cosentyx (secukinumab), the first interleukin-17A approved to treat psoriasis.

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FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab

The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).

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Pfizer’s Besponsa Approved in EU

The European Commission approved Besponsa as monotherapy for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

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FDA Approves Vectibix For Use In Wild-Type RAS Metastatic Colorectal Cancer

Amgen announced that the U.S. FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer.

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