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FDA expands use of ovarian cancer drug

The FDA expanded the use of Lynparza, sold by AstraZeneca Plc and Merck & Co. Inc., and approved a new two-tablet regimen for the drug.

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FDA approves rare blood cancer drug

The U.S. Food and Drug Administration approved Pfizer Inc.’s rare blood cancer drug Besponsa with a boxed warning.

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FDA Accepts Adcetris Supplemental BLA for CTLC

The FDA accepted for filing Seattle Genetics’ supplemental Biologics License Application for Adcetris in patients with cutaneous T-cell lymphoma.

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Flimsy evidence behind many FDA approvals

Many drugs granted accelerated approval and most high-risk medical devices approved by FDA lack clear evidence of safety and effectiveness, per JAMA reports.

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FDA Removes Clinical Hold on CEL-SCI Study

CEL-SCI received a letter from the U.S. FDA stating that the clinical hold that had been imposed on the company’s Phase 3 cancer study with Multikine was removed.

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Gilead’s HIV Triple Combo: Sped-Up FDA Review

Feb. 12, 2018, is the day the U.S. FDA is expected to review Gilead Sciences’ HIV treatment that some analysts suggest could become a blockbuster.

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FDA clears Optovue’s epi-mapping software

The FDA cleared Optovue’s epithelial thickness mapping software (epi-mapping) for quantitative measurements of the epithelial and stromal layers of the cornea.

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Vernalis receives CRL for cough & cold drug

Shares in Vernalis fell more than 15 percent as the British biotech company announced a fresh setback for a key new drug in the United States.

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Drug Enforcement Administration proposes cutting production of some opioid painkillers

The U.S. DEA proposed a 20 percent reduction in the manufacture of certain commonly prescribed opioid painkillers as well as other controlled substances for 2018.

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First-Ever Drug to Treat All Hep C Forms Approved

The hepatitis C market got more crowded after the FDA approved AbbVie’s Mavyret, a drug that will treat all types of HCV in an eight-week time frame.

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Pharma Scores Big Win: Trump to Ink FDA User Fee Bill, Saving 5,000 Jobs

Hours before the U.S. Senate recessed for the remainder of summer 2017, legislators approved key legislation that will provide the necessary funding to keep the U.S. FDA operating efficiently.

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FDA panel votes against J&J arthritis drug

The benefits of Johnson & Johnson’s experimental rheumatoid arthritis drug sirukumab do not outweigh the risks, an advisory panel to the U.S. FDA concluded.

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U.S. FDA Approves Expanded Labeling for Epclusa

The FDA approved updated labeling for Gilead Sciences’ chronic hepatitis C virus drug Epclusa to include use in patients co-infected with HIV.

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FDA approves leukemia treatment

The U.S. FDA approved Celgene Corp. and Agios Pharmaceuticals Inc.’s oral treatment for acute myeloid leukemia patients with a specific genetic mutation.

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AstraZeneca gets breakthrough status for blood cancer drug

U.S. regulators awarded AstraZeneca’s blood cancer drug acalabrutinib “breakthrough” status for the treatment of patients with mantle cell lymphoma, a rare type of blood cancer.

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As Congress struggles with healthcare reform, Gottlieb’s FDA is taking action

While the nation’s media was focusing on the unsuccessful attempts by Republicans to pass a successor to Obamacare, a fascinating sideshow has developed in nearby White Oak, Maryland, home of the Food and Drug Administration.

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J&J RA drug sirukumab raises safety concerns

There were more deaths in patients taking J&J’s experimental rheumatoid arthritis drug sirukumab than among those taking a placebo, FDA staff reviewers said.

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Abilify Maintena Approved by FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder

Otsuka Pharmaceutical and H. Lundbeck’s Abilify Maintena (aripiprazole) was approved by the U.S. FDA for the maintenance monotherapy treatment of bipolar I disorder in adults.

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Amgen gets fast FDA review for adding heart benefits to cholesterol drug label

Amgen Inc. said the U.S. FDA granted priority review to the company’s request to add important heart safety data to the label of its expensive injectable cholesterol drug Repatha.

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Safety concerns for Dynavax hep B vaccine

A preliminary advisory committee report by the FDA once again pointed to some serious safety issues with Dynavax Technologies’ troubled hepatitis B treatment Heplisav-B.

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