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FDA to ban flavored e-cigs at U.S. convenience stores

The FDA announced sweeping new restrictions on flavored tobacco products, including electronic cigarettes popular among teenagers in an effort to prevent a new generation of nicotine addicts.

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Roche’s Tecentriq wins fast FDA review in tough-to-treat breast cancer

Roche’s Tecentriq will get a speedy review by U.S. regulators in a tough-to-treat form of breast cancer, seeking to be the first company to have an immunotherapy win approval in this indication.

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Amarin Plans to Seek FDA Approval for CV Indication for Fish Oil Drug

Clinical data for a fish-oil-based drug from Amarin Corporation confirmed the drug’s ability to reduce the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death.

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Mylan and Theravance’s COPD treatment gets FDA approval

Theravance Biopharma Inc. and partner Mylan NV won U.S. regulatory approval for their treatment Yupelri for a chronic lung condition that causes breathing-related problems.

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U.S. to restrict e-cigarette flavors

The FDA will issue a sales ban on fruit and candy flavored electronic cigarettes in convenience stores and gas stations in a move to counter a surge in teenage use of e-cigarettes.

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FDA approves Empliciti for new MM indication

Bristol-Myers Squibb snagged regulatory approval from the U.S. FDA for Empliciti (elotuzumab) for adults with multiple myeloma who have received at least two prior therapies.

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Sanofi and Regeneron’s Dupixent gets more positive feedback from U.S. FDA

The U.S. Food and Drug Administration accepted for priority review the license application for the use of Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis

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Depression treatment fails to get FDA panel backing

An FDA advisory panel voted against approving Alkermes Plc’s depression treatment ALKS 5461 in patients with an inadequate response to standard antidepressant therapies.

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FDA Approves Another Indication for Merck’s Keytruda

Merck’s blockbuster anti-PD-1 therapy Keytruda won FDA approval in combination with chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.

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FDA approves Novartis’ copy of bestseller Humira

The U.S. Food and Drug Administration approved Novartis AG’s copy of Humira, the world’s bestselling prescription medicine developed by U.S.-based AbbVie Inc.

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FDA approves TherapeuticsMD’s menopause drug

The U.S. Food and Drug Administration approved TherapeuticsMD’s oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats.

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FDA declines to approve pre-filled syringe version of Regeneron’s Eylea

The U.S. FDA declined to approve a pre-filled syringe version of Regeneron Pharmaceuticals Inc.’s blockbuster eye drug Eylea.

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FDA approves first new flu drug in almost two decades

Japan’s Shionogi and Swiss drugmaker Roche won U.S. FDA approval for Xofluza, the first new flu drug approved by the regulatory agency in nearly 20 years.

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Sanofi’s eczema product Dupixent wins FDA approval to treat asthma

Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.

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Shire’s Takhzyro for rare swelling disorder wins European panel green light

An EMA panel recommended approving a potential blockbuster drug from Shire Plc to treat a rare hereditary disease.

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Sanofi receives positive CHMP opinion for dengue vaccine

The European Medicines Agency’s CHMP adopted a positive opinion for the marketing authorization of Sanofi’s dengue vaccine.

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FDA Proposes Steps to Standardize Generic Drugs Globally

U.S. Food and Drug Administration Commissioner Scott Gottlieb announced that the regulatory agency is relaunching the Drug Competition Action Plan in 2019 with some additional initiatives.

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FDA snubs Novartis bid to repurpose inflammation drug for heart attacks

The U.S. Food and Drug Administration rejected Novartis’ bid to repurpose canakinumab, a drug already approved for rare inflammatory diseases, for use in a group of heart attack survivors.

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FDA approves Pfizer’s breast cancer drug Talzenna

The U.S. Food and Drug Administration approved Pfizer Inc.’s Talzenna (talazoparib) for an advanced form of breast cancer.

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FDA Advisory Committee Recommends AcelRx’s Opioid Drug Dsuvia

The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend AcelRx Pharmaceuticals’ Dsuvia to manage moderate-to-severe pain.

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