Artwork

コンテンツは Emma Nichols, PhD and Emma Hitt Nichols によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Emma Nichols, PhD and Emma Hitt Nichols またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal
Player FM -ポッドキャストアプリ
Player FMアプリでオフラインにしPlayer FMう!

Velsipity (Etrasimod) for UC; Braftovi (encorafenib) and Mektovi (binimetinib) for NSCLC; Patisiran in ATTR amyloidosis; Digital Health Advisory Committee

7:34
 
シェア
 

Fetch error

Hmmm there seems to be a problem fetching this series right now. Last successful fetch was on July 29, 2024 20:37 (3M ago)

What now? This series will be checked again in the next hour. If you believe it should be working, please verify the publisher's feed link below is valid and includes actual episode links. You can contact support to request the feed be immediately fetched.

Manage episode 407556903 series 3561458
コンテンツは Emma Nichols, PhD and Emma Hitt Nichols によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Emma Nichols, PhD and Emma Hitt Nichols またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal

Check out our free downloads at nascentmc.com:

See the full write ups for today's episode at nascentmc.com/podcast

Here are the highlights:

Velsipity (Etrasimod) for UC: The FDA has approved Velsipity (etrasimod) for treating moderate to severe active ulcerative colitis (UC) in adults. Etrasimod, an oral medication manufactured by Pfizer, was based on safety and efficacy data from the ELEVATE UC 52 and ELEVATE UC 12 trials, making it the second S1P class agent approved for UC in the United States. The first agent, ozanimod (Zeposia), received FDA approval in May 2021.

Braftovi (encorafenib) and Mektovi (binimetinib) for NSCLC:The FDA has granted approval for the combination of encorafenib and binimetinib to treat BRAF V600E–mutant, metastatic non–small cell lung cancer (NSCLC). The approval, supported by the phase 2 PHAROS study, showed a 75% objective response rate (ORR) in treatment-naive patients. This combination was previously approved for unresectable or metastatic melanoma with a BRAF mutation.

Edison System for Non-Invasive Destruction of Liver Tumors:The FDA has authorized the marketing of the HistoSonics Inc. Edison System for non-invasive destruction of liver tumors. The system utilizes a non-thermal, mechanical process of focused ultrasound to create small, vapor-filled cavities (cavitation) without heat, mechanically destroying and liquefying targeted liver tissue, including tumors. This technology is suitable for patients with sufficient functional liver reserve.

Complete Response Letter for Patisiran ATTR amyloidosis:The FDA declined to approve patisiran for ATTR amyloidosis despite a favorable recommendation from advisers. The FDA noted that patisiran did not significantly improve the condition of patients with heart muscle issues or cardiomyopathy caused by ATTR amyloidosis. Patisiran, branded as Onpattro, is already approved to treat nerve damage in adult patients with hereditary ATTR amyloidosis.

FDA Creates a Digital Health Advisory Committee:The FDA has established a Digital Health Advisory Committee to address complex issues related to digital health technologies, including AI/ML, augmented reality, virtual reality, and more. This committee will provide expertise and perspective to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with digital health technologies and is expected to be fully operational in 2024.

Intro and outro music

Garden Of Love by Pk jazz Collective

  continue reading

60 つのエピソード

Artwork
iconシェア
 

Fetch error

Hmmm there seems to be a problem fetching this series right now. Last successful fetch was on July 29, 2024 20:37 (3M ago)

What now? This series will be checked again in the next hour. If you believe it should be working, please verify the publisher's feed link below is valid and includes actual episode links. You can contact support to request the feed be immediately fetched.

Manage episode 407556903 series 3561458
コンテンツは Emma Nichols, PhD and Emma Hitt Nichols によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Emma Nichols, PhD and Emma Hitt Nichols またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal

Check out our free downloads at nascentmc.com:

See the full write ups for today's episode at nascentmc.com/podcast

Here are the highlights:

Velsipity (Etrasimod) for UC: The FDA has approved Velsipity (etrasimod) for treating moderate to severe active ulcerative colitis (UC) in adults. Etrasimod, an oral medication manufactured by Pfizer, was based on safety and efficacy data from the ELEVATE UC 52 and ELEVATE UC 12 trials, making it the second S1P class agent approved for UC in the United States. The first agent, ozanimod (Zeposia), received FDA approval in May 2021.

Braftovi (encorafenib) and Mektovi (binimetinib) for NSCLC:The FDA has granted approval for the combination of encorafenib and binimetinib to treat BRAF V600E–mutant, metastatic non–small cell lung cancer (NSCLC). The approval, supported by the phase 2 PHAROS study, showed a 75% objective response rate (ORR) in treatment-naive patients. This combination was previously approved for unresectable or metastatic melanoma with a BRAF mutation.

Edison System for Non-Invasive Destruction of Liver Tumors:The FDA has authorized the marketing of the HistoSonics Inc. Edison System for non-invasive destruction of liver tumors. The system utilizes a non-thermal, mechanical process of focused ultrasound to create small, vapor-filled cavities (cavitation) without heat, mechanically destroying and liquefying targeted liver tissue, including tumors. This technology is suitable for patients with sufficient functional liver reserve.

Complete Response Letter for Patisiran ATTR amyloidosis:The FDA declined to approve patisiran for ATTR amyloidosis despite a favorable recommendation from advisers. The FDA noted that patisiran did not significantly improve the condition of patients with heart muscle issues or cardiomyopathy caused by ATTR amyloidosis. Patisiran, branded as Onpattro, is already approved to treat nerve damage in adult patients with hereditary ATTR amyloidosis.

FDA Creates a Digital Health Advisory Committee:The FDA has established a Digital Health Advisory Committee to address complex issues related to digital health technologies, including AI/ML, augmented reality, virtual reality, and more. This committee will provide expertise and perspective to improve the FDA's understanding of the benefits, risks, and clinical outcomes associated with digital health technologies and is expected to be fully operational in 2024.

Intro and outro music

Garden Of Love by Pk jazz Collective

  continue reading

60 つのエピソード

ทุกตอน

×
 
Loading …

プレーヤーFMへようこそ!

Player FMは今からすぐに楽しめるために高品質のポッドキャストをウェブでスキャンしています。 これは最高のポッドキャストアプリで、Android、iPhone、そしてWebで動作します。 全ての端末で購読を同期するためにサインアップしてください。

 

クイックリファレンスガイド