Tag #Fda Approval

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es.euronews.com

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Sep 9, 10:16

LSD Shows Promise in Treating Anxiety, Paving Way for Further Research and Potential FDA Approval

A study by Mindmed found that LSD significantly reduced anxiety symptoms in patients with generalized anxiety disorder, lasting up to three months, prompting further research and potential FDA approval.

LSD Shows Promise in Treating Anxiety, Paving Way for Further Research and Potential FDA Approval

A study by Mindmed found that LSD significantly reduced anxiety symptoms in patients with generalized anxiety disorder, lasting up to three months, prompting further research and potential FDA approval.

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What are the key findings of the Mindmed study on LSD's effect on anxiety?

The study, published in the Journal of the American Medical Association, showed that two higher doses of LSD (100 micrograms being most effective) significantly reduced anxiety symptoms in patients with moderate to severe generalized anxiety disorder compared to placebo. These benefits lasted up to three months, with 65% of patients on the highest dose still showing benefits at 12 weeks and almost 50% in remission.

npr.org

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May 22, 07:12

FDA Approves First Blood Test for Alzheimer's

The FDA approved a new blood test for Alzheimer's disease, increasing diagnostic accuracy to over 90% and improving access to treatment, particularly for those in underserved areas.

FDA Approves First Blood Test for Alzheimer's

The FDA approved a new blood test for Alzheimer's disease, increasing diagnostic accuracy to over 90% and improving access to treatment, particularly for those in underserved areas.

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What are the advantages of this blood test compared to existing diagnostic methods for Alzheimer's?

This blood test offers a less invasive and more accessible alternative to PET scans and spinal taps, increasing the number of diagnoses, especially in underserved areas. The higher accuracy will enable earlier treatment with amyloid-reducing drugs for a larger patient population.

forbes.com

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May 16, 16:11

AbbVie Stock Surges 10% on Emrelis Approval and Immunology Growth

AbbVie's stock price surged 10% in six months due to FDA approval of Emrelis for lung cancer and exceptional growth (Skyrizi +71%, Rinvoq +57%) in its immunology portfolio during Q1 2025, despite high valuation and concerns about drug price controls.

AbbVie Stock Surges 10% on Emrelis Approval and Immunology Growth

AbbVie's stock price surged 10% in six months due to FDA approval of Emrelis for lung cancer and exceptional growth (Skyrizi +71%, Rinvoq +57%) in its immunology portfolio during Q1 2025, despite high valuation and concerns about drug price controls.

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What is the immediate impact of FDA approval for Emrelis and the growth of AbbVie's immunology portfolio on the company's stock performance and market position?

AbbVie (ABBV) received FDA approval for Emrelis, a new drug targeting c-Met protein-driven lung cancer. This, coupled with strong growth in its immunology portfolio (Skyrizi +71%, Rinvoq +57% YoY Q1 2025), has driven a 10% stock increase in the last six months, outperforming the S&P Healthcare index.

forbes.com

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Apr 30, 16:13

FDA Approves First Gene Therapy for RDEB, Showcasing Innovative Funding Model

The FDA approved ZEVASKYN, the first autologous cell-based gene therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), a significant advancement driven by EB Research Partnership's innovative venture philanthropy model, offering hope to 500,000 people globally.

FDA Approves First Gene Therapy for RDEB, Showcasing Innovative Funding Model

The FDA approved ZEVASKYN, the first autologous cell-based gene therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), a significant advancement driven by EB Research Partnership's innovative venture philanthropy model, offering hope to 500,000 people globally.

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What is the significance of the FDA's approval of ZEVASKYN for Recessive Dystrophic Epidermolysis Bullosa (RDEB)?

The FDA approved ZEVASKYN, the first autologous cell-based gene therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB). Clinical trials showed 81% of large chronic wounds treated with ZEVASKYN healed by 50% or more after six months, compared to 16% with standard care. This offers new hope and treatment options for the estimated 500,000 people worldwide with RDEB.

edition.cnn.com

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Jan 31, 07:09

FDA Approves First New Pain Reliever in Over Two Decades

The FDA approved Journavx (suztrigine), a new non-opioid pain reliever, offering a safer alternative to opioids; clinical trials showed effectiveness in reducing post-surgical pain, but further research is needed for chronic pain.

FDA Approves First New Pain Reliever in Over Two Decades

The FDA approved Journavx (suztrigine), a new non-opioid pain reliever, offering a safer alternative to opioids; clinical trials showed effectiveness in reducing post-surgical pain, but further research is needed for chronic pain.

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What is the significance of the FDA's approval of Journavx, and how does it address the current healthcare landscape?

The FDA approved Journavx (suztrigine), a new non-opioid pain reliever, offering an alternative to opioids. This 50mg pill, taken every 12 hours after a larger initial dose, showed effectiveness in reducing pain after surgeries in clinical trials. About half of the 80 million Americans who receive prescriptions for moderate to severe pain annually receive opioid-based medications, highlighting the need for safer alternatives.

cnn.com

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Jan 31, 04:09

FDA Approves First New Painkiller in Over Two Decades

The FDA approved Journavx (suztrigine), a new non-opioid pain reliever, offering a safer alternative to opioids; clinical trials showed effectiveness in reducing post-surgical pain, though further research on chronic pain is needed.

FDA Approves First New Painkiller in Over Two Decades

The FDA approved Journavx (suztrigine), a new non-opioid pain reliever, offering a safer alternative to opioids; clinical trials showed effectiveness in reducing post-surgical pain, though further research on chronic pain is needed.

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How does Journavx's mechanism of action differ from opioids, and what are the implications for addiction and pain relief?

Journavx's mechanism differs from opioids by blocking pain signals before they reach the brain, preventing addiction potential. Clinical trials demonstrated pain reduction comparable to Vicodin for post-surgical pain, although its efficacy for chronic pain like sciatica requires further investigation. The drug's development was inspired by a unique Pakistani family immune to pain.

npr.org

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May 24, 04:10

FDA-Approved At-Home Cervical Cancer Test Aims to Increase Early Detection

A new at-home cervical cancer screening test, approved by the FDA, offers a convenient and less invasive alternative to traditional methods, potentially increasing early detection rates and reducing mortality in California, with plans for nationwide rollout.

FDA-Approved At-Home Cervical Cancer Test Aims to Increase Early Detection

A new at-home cervical cancer screening test, approved by the FDA, offers a convenient and less invasive alternative to traditional methods, potentially increasing early detection rates and reducing mortality in California, with plans for nationwide rollout.

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What is the immediate impact of the FDA-approved at-home cervical cancer screening test on accessibility and early detection rates?

A new at-home cervical cancer screening test, developed by Teal Health and recently FDA-approved, is now available in California. The test, which involves a simple vaginal sample collection and mail-in process, aims to increase screening rates by improving convenience and reducing discomfort. This could lead to earlier detection and treatment of cervical cancer, a preventable disease that disproportionately affects women.

cnn.com

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May 18, 07:09

FDA Approves Novavax Covid-19 Vaccine for Specific High-Risk Groups

The FDA approved Novavax's protein-based Covid-19 vaccine for those 65 and older and individuals 12 and older with underlying conditions, after a six-week delay to gather more data and mandate post-marketing safety studies on rare heart inflammation risks.

FDA Approves Novavax Covid-19 Vaccine for Specific High-Risk Groups

The FDA approved Novavax's protein-based Covid-19 vaccine for those 65 and older and individuals 12 and older with underlying conditions, after a six-week delay to gather more data and mandate post-marketing safety studies on rare heart inflammation risks.

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How does the FDA's request for additional data and the mandated post-marketing studies reflect the agency's approach to vaccine safety?

Novavax's vaccine approval targets older adults and those with pre-existing conditions, groups identified as most likely to receive seasonal Covid-19 vaccinations. This targeted approach follows a delay by the FDA for additional data, highlighting the rigorous safety standards for vaccine approval. Post-market studies will assess the risk of myocarditis and pericarditis, conditions rarely reported but observed in Novavax vaccine trials.

edition.cnn.com

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May 10, 16:11

FDA Approves First At-Home Cervical Cancer Screening Device

The FDA approved Teal Wand, an at-home self-collection device for cervical cancer screening, allowing women to collect samples at home and mail them for HPV testing using Roche's test, aiming to increase screening rates and improve outcomes.

FDA Approves First At-Home Cervical Cancer Screening Device

The FDA approved Teal Wand, an at-home self-collection device for cervical cancer screening, allowing women to collect samples at home and mail them for HPV testing using Roche's test, aiming to increase screening rates and improve outcomes.

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What is the significance of the FDA's approval of the Teal Wand for at-home cervical cancer screening?

The FDA approved Teal Wand, an at-home self-collection device for cervical cancer screening. This allows women to collect vaginal samples at home and mail them for HPV testing, eliminating the need for in-person appointments. The test has the same accuracy as provider-collected samples.

forbes.com

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Apr 17, 22:11

FDA Approves Precision Neuroscience Brain Implant Amidst Reported Regulatory Slowdowns

The FDA approved Precision Neuroscience's minimally invasive brain implant designed to help paralyzed patients regain function, despite reports of slowed drug development under the Trump administration.

FDA Approves Precision Neuroscience Brain Implant Amidst Reported Regulatory Slowdowns

The FDA approved Precision Neuroscience's minimally invasive brain implant designed to help paralyzed patients regain function, despite reports of slowed drug development under the Trump administration.

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How do reported FDA delays under the Trump administration affect biotech companies' clinical trials and drug development?

Precision Neuroscience, co-founded by a Neuralink cofounder, secured $155 million in funding and competes with companies like Neuralink and Synchron. The approval highlights advancements in neurotechnology despite reported regulatory challenges and contrasts with Neuralink's less transparent approach and reported safety concerns.

theglobeandmail.com

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Jan 31, 04:09

FDA Approves Non-Addictive Pain Pill Journavx

The U.S. Food and Drug Administration approved Vertex Pharmaceuticals' Journavx, a non-addictive pain medication, for short-term pain relief following surgery or injury; studies showed modest effectiveness compared to opioids, but its different mechanism offers a new approach, although its $15.50 pr...

FDA Approves Non-Addictive Pain Pill Journavx

The U.S. Food and Drug Administration approved Vertex Pharmaceuticals' Journavx, a non-addictive pain medication, for short-term pain relief following surgery or injury; studies showed modest effectiveness compared to opioids, but its different mechanism offers a new approach, although its $15.50 pr...

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What is the significance of the FDA's approval of Journavx for addressing the opioid crisis?

The FDA approved Journavx, a non-opioid pain medication from Vertex Pharmaceuticals, for short-term pain relief. While not significantly more effective than opioid combinations in trials, it offers a non-addictive alternative with a different mechanism of action. The drug's high price, $15.50 per pill, contrasts sharply with cheaper opioid generics.

cnbc.com

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Jan 31, 01:09

FDA Approves Novel Non-Opioid Painkiller Journavx

The FDA approved Vertex's non-opioid painkiller, Journavx, for moderate-to-severe acute pain, offering an addiction-free alternative impacting 80 million annual U.S. patients and potentially generating over $1 billion in annual sales.

FDA Approves Novel Non-Opioid Painkiller Journavx

The FDA approved Vertex's non-opioid painkiller, Journavx, for moderate-to-severe acute pain, offering an addiction-free alternative impacting 80 million annual U.S. patients and potentially generating over $1 billion in annual sales.

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How does Journavx's mechanism of action differ from opioids, and what were the key findings regarding its efficacy and safety in clinical trials?

Journavx, unlike opioids, blocks pain signals at their origin, preventing addiction. Two late-stage studies showed Journavx's superior effectiveness to placebo in reducing post-surgical pain, despite not outperforming hydrocodone/acetaminophen. Lower adverse effects were observed with Journavx compared to placebo.

Showing 1 to 12 of 18 results