The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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The Pharma Data

NOVEMBER 18, 2020

. “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.

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pharmaphorum

NOVEMBER 16, 2021

Now, FDA approval means that it can continue to be sold outside of the public health emergency. Using the AI, ETTs are automatically identified in chest X-ray images, providing feedback to the clinician on positioning within seconds and warning them if it hasn’t been place correctly.

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pharmaphorum

DECEMBER 15, 2022

Digital health company MedCognetics has picked up an FDA approval for QmTRIAGE, its artificial intelligence-powered software for detecting breast cancer in medical images. The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world.

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Radiology FDA Approval Licensing Licensing 59

FDA Law Blog

NOVEMBER 5, 2023

Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. The comprehensive agenda for the symposium can be accessed in its entirety here.

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XTalks

APRIL 27, 2021

With the authorization, the IpsiHand System becomes the first non-invasive neurological rehabilitation device to receive FDA approval in the rapidly growing brain-computer interface space.

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XTalks

JANUARY 26, 2024

As of October 19, 2023, there were 692 FDA-approved devices linked to AI/ML , underscoring the expanding role of these technologies in healthcare. It promotes unique insights and improvements in tumor biology understanding through the collaboration of biological and computer scientists.

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XTalks

MARCH 27, 2023

The primary endpoints were global cure (consisting of clinical cure, radiological cure and mycological eradication) at 14 days for the European Medical Agency (EMA), and a 30-day all-cause mortality for the US FDA. Rezafungin met the endpoints outlined by both the EMA and FDA.

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The Pharma Data

DECEMBER 15, 2020

” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA.

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XTalks

JUNE 12, 2023

Additionally, Abbott launched over 125 new products in 2022, in conjunction with a series of FDA approvals. This system is the first and only FDA-approved heart failure monitoring system that enables physicians to track changes in pulmonary artery pressure. The CardioMEMs HF system was another crucial launch for Abbott.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

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XTalks

JULY 10, 2024

Related: Abbott’s HPV Test Gets FDA Approval for High-Risk HPV Detection and Cervical Cancer Screening Hepatitis C Drug Market Trends The global hepatitis C drug market was valued at $7.86 billion in 2018 and is projected to reach $9.84 billion by 2032, growing at a compound annual growth rate (CAGR) of 1.8 percent.

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The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., Ono Pharmaceutical Co.

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XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

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Intouch Solutions

JUNE 30, 2022

The Roblox pseudo-metaverse now includes a partnership with ADHD therapy (gizmodo.com) – Roblox is partnering with Akili Interactive, creators of EndeavorRx (a game that is an FDA-approved ADHD treatment for children 8-12), to “create new ways for patients to engage in health through the Roblox platform.”

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XTalks

AUGUST 30, 2022

Nusinersen was the first FDA-approved treatment for spinal muscular atrophy (SMA), the first approved nucleic-acid therapeutic for a neurologic disease and the first approved drug to correct defective splicing. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs.

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The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. It is characterized by progressive fibrosis, lung scarring, and a radiological pattern known as usual interstitial pneumonia, or UIP.

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