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FDA to review effectiveness of abuse deterrent opioid drugs

FDA Commissioner Scott Gottlieb continues his fightback against the US opioid crisis after requesting an unprecedented recall of Endo Pharmaceuticals’ painkiller Opana ER by calling for a review of all ‘abuse deterrent’ opioid drugs to confirm their efficacy at preventing addiction and abuse.

Bron: Pharmafile Meer lezen »

FDA Approves First Generic Version of Truvada

The Food and Drug Administration (FDA) has approved Teva’s Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200mg/300mg, the first generic version of  Gilead’s Truvada 200mg/300mg. Teva’s product was determined to be bioequivalent and therapeutically equivalent to the reference drug.

Bron: Monthly Prescribing Reference (MPR): Drug News Meer lezen »

Immuno-oncology upset in bladder cancer

  Roche and Genentech’s checkpoint inhibitor atezolizumab did not improve overall survival in a confirmatory phase III trial in patients with advanced bladder cancer. The FDA granted accelerated approval to the anti-programmed cell death protein 1 ligand 1 (PDL1) antibody for this indication in 2016

Bron: Nature Reviews Drug Discovery Meer lezen »

New FDA commissioner Gottlieb unveils price-fighting strategies

During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices.

Bron: FiercePharma Meer lezen »

Merck’s Keytruda picks up a trifecta with FDA approval to treat rare tumor type

Talk about going on a roll. Merck’s Keytruda nabbed its third FDA approval in two weeks on Tuesday, becoming the first checkpoint inhibitor to pick up an approval to treat microsatellite instability-high cancer, a rare tumor type identified with genetic testing.

Bron: FiercePharma Meer lezen »

Opioid crisis “highest initial priority” for new FDA Commissioner

Scott Gottlieb, the newly appointment FDA Commissioner, has indicated that his first priority is to tackle the opioid crisis currently wracking the US, through messages on the FDA blog and in an internal email to FDA employees. He stated that the agency needed to examine what “additional, forceful steps” it could take to address the […]

Bron: Pharmafile Meer lezen »

FDA demands new warnings for J&J diabetes drug over amputation risk

Johnson & Johnson has found itself in deep water again over the potentially harmful effects of its products. This time it has found itself the target of FDA scrutiny, as the organisation is now requiring the company to add new precautionary labelling to its diabetes treatment Invokana (canagliflozin), warning users of the risk of foot […]

Bron: Pharmafile Meer lezen »

Alzheimer’s experts call for changes in FDA drug approval standards

Leading Alzheimer’s disease researchers and a prominent patient advocate today published an analysis, “Single Endpoint for New Drug Approvals for Alzheimer’s Disease,” urging the Food and Drug Administration (FDA) to clarify and modernize its current approach for approving new treatments for Alzheimer’s disease.

Bron: World Pharma News Meer lezen »

ALS treatment gets U.S. FDA approval

The Food and Drug Administration on Friday approved Mitsubishi Tanabe Pharma Corp’s treatment for fatal neurological disorder amyotrophic lateral sclerosis (ALS), marking the first such U.S. regulatory approval in more than two decades. The drug, known chemically as edaravone, has been sold in Japan and South Korea since 2015.

Bron: Reuters Meer lezen »

FDA Approves Once-Monthly Dosing for Praluent

Sanofi US and Regeneron announced that the Food and Drug Administration (FDA) has approved a new supplemental Biologics License Application (sBLA) for a once-monthly 300mg dose of Praluent (alirocumab) injection for the treatment of adults with high low-density lipoprotein (LDL) cholesterol.

Bron: Monthly Prescribing Reference (MPR): Drug News Meer lezen »

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