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"approval"

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

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... Read More »

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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… Read More »

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The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses. Cataracts are a common eye condition where… Read More »

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Flimsy evidence behind many FDA approvals

Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in the Journal of the American Medical Association. The Accelerated Approval pathway makes potentially promising investigational medicines available for use... Read More »

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Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in the Journal of the American Medical Association. The Accelerated Approval pathway makes potentially promising investigational medicines available for use… Read More »

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FDA clears first neonatal magnetic resonance imaging device

Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum... Read More »

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Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum… Read More »

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The FDA Approved the First New Sickle Cell Drug in 20 Years…But It’s Not a Cure

News that the Food and Drug Administration (FDA) approved the first new drug to treat sickle cell in nearly 20 years last Friday understandably drew cheers from patients and advocates who have stood by with bated breath for a breakthrough. But as laudable as the milestone may be, the treatment’s limited reach underscores just how... Read More »

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News that the Food and Drug Administration (FDA) approved the first new drug to treat sickle cell in nearly 20 years last Friday understandably drew cheers from patients and advocates who have stood by with bated breath for a breakthrough. But as laudable as the milestone may be, the treatment’s limited reach underscores just how… Read More »

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FDA approves first new drug for ALS treatment in 22 years

The US Food and Drug Administration has approved the first new drug for the treatment of amyotrophic lateral sclerosis, or ALS, in more than two decades. The FDA announced Friday that Radicava, also known as edaravone, has been approved for use in the United States. The only other drug specifically for the treatment of ALS... Read More »

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The US Food and Drug Administration has approved the first new drug for the treatment of amyotrophic lateral sclerosis, or ALS, in more than two decades. The FDA announced Friday that Radicava, also known as edaravone, has been approved for use in the United States. The only other drug specifically for the treatment of ALS… Read More »

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