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FDA approves first biosimilar for the treatment of certain breast and stomach cancers
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- Written by IVPost
- Category: Latest News
The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.
FDA Approval of a new formulation of buprenorphine
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- Written by Commissioner Scott Gottlieb, M.D.
- Category: Latest News
With the approval today of a monthly formulation of the drug buprenorphine for the treatment of opioid use disorder, patients have access to a new and longer-acting option for the treatment of opioid addiction. Millions of Americans are suffering from addiction to opioid drugs, and millions more are worried that the overdose epidemic could claim the lives of a friend or loved one. We need immediate actions to help those suffering from an opioid use disorder transition to lives of sobriety.
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
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- Written by IVP
- Category: Medical News
The U.S. Food and Drug Administration approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days.
Supplement Sellers Settle FTC, State of Maine False Advertising Charges
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- Written by IVPost
- Category: Health News
A health products company and its owner have agreed to settle charges by the Federal Trade Commission and the State of Maine that they deceived consumers with promises that their products could treat everything from arthritis to memory loss. The proposed federal court order announced today bars the defendants from engaging in a wide range of business practices that the agencies allege have caused financial injury to consumers.
Testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH”
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- Written by FDA Commissioner Scott Gottlieb, M.D.
- Category: Latest News
Chairman Burgess, Ranking Member Greene, members of the subcommittee: Thank you for the opportunity to testify today on the anniversary of the 21st Century Cures Act, and to update you on FDA's progress in implementing the provisions of this landmark legislation.
Results From the President's Emergency Plan for AIDS Relief
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- Written by State Department
- Category: Latest News
On the eve of World AIDS Day 2017, the United States announced that the impact of President's Emergency Plan for AIDS Relief (PEPFAR) has reached historic highs through the program's rapid acceleration of HIV prevention and treatment efforts, driven by transparent, accountable, and cost-effective investments.
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