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Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

Celgene Corporation announced that the company submitted a New Drug Application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).

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EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics

The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.

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Novartis wins EU approval for blood cancer therapy Kymriah

Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.

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FDA Rejects Allergan’s Uterine Fibroid Treatment Following EMA Concerns Over Liver Damage

The U.S. Food and Drug Administration rejected Allergan’s New Drug Application for ulipristal acetate.

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Toxin at heart of drug recall shows holes in medical safety net

A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.

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EU says second China company made tainted heart drug

The European Medicines Agency said a second Chinese contract manufacturer, Zhejiang Tianyu, produced a common blood pressure and heart drug with an impurity that could cause cancer.

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JHL Biotech Receives Positive CHMP Scientific Advice for Global Phase III Clinical Trial of Proposed Bevacizumab Biosimilar to Treat Lung Cancer

JHL Biotech received a positive Scientific Advice from the Committee for Medicinal Products for Human Use of the European Medicines Agency related to the EU approval pathway for its proposed bevacizumab biosimilar JHL1149 to treat patients with non-small cell lung cancer.

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European Committee Recommends Approval For Alnylam’s Rare Disease Drug

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a Positive Opinion over Alnylam Pharmaceuticals’ patisiran for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or stage 2 polyneuropathy.

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GSK’s severe pediatric asthma drug wins European panel thumbs-up

GlaxoSmithKline’s Nucala won a key recommendation from a European Medicines Agency panel for use in the treatment of children with severe asthma.

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AstraZeneca’s key lung cancer drug wins European panel thumbs-up

AstraZeneca’s cancer drug Imfinzi won a key recommendation from a European Medicines Agency (panel less than six months after the first global approvals in Western markets.

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