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Experts urge FDA to set clear safety and access standards for psychedelic drugs (September 14)

Experts urge FDA to set clear safety and access standards for psychedelic drugs (September 14)

(Corrects quote attribution in paragraph 8 of September 14 story from Lynn Watkins, a U.S.
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FDA Approves Moderna's mRNA Flu Vaccine for Adults 50 and Older

FDA Approves Moderna's mRNA Flu Vaccine for Adults 50 and Older

The U.S. Food and Drug Administration (FDA) has approved Moderna’s mFLUSIVA, the first influenza vaccine utilizing mRNA technology, for individuals aged 50 and older. This approval introduces a new option for older Americans, a demographic that accounts for the vast majority of the tens of thousands of annual flu-related deaths. The mRNA vaccine platform delivers a genetic script that instructs the body's cells to produce a piece of the flu virus, thereby training the immune system. This method allows for quicker adaptation to evolving virus strains compared to traditional egg-based vaccines, which have been in use for 80 years and require months to produce. Clinical trials demonstrated that mFLUSIVA (mRNA-1010) was approximately 26.6% more effective at preventing laboratory-confirmed influenza illness than a traditional flu vaccine and elicited a stronger immune response in adults 65 and older, with similar rates of rare severe side effects. The vaccine's safety has been evaluated in roughly 70,000 people...
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US regulators urge more research on testosterone therapy for women as experts debate benefits, risks

US regulators urge more research on testosterone therapy for women as experts debate benefits, risks

By Siddhi Mahatole and Padmanabhan Ananthan Sept 17 (Reuters) - US health regulators on Thursday called for more data on testosterone therapies for women, with FDA officials urging manufacturers to conduct studies that could support future approvals of female-specific products.
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US regulators examine testosterone therapy for women as experts debate evidence, safety

US regulators examine testosterone therapy for women as experts debate evidence, safety

By Siddhi Mahatole and Padmanabhan Ananthan Sept 17 (Reuters) - US health regulators weighing testosterone use in menopausal women at a public meeting on Thursday were told by some experts that a female-specific product was needed while others pointed to gaps in evidence on the hormone's broader
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US regulators to examine testosterone therapy as use by menopausal women rises

US regulators to examine testosterone therapy as use by menopausal women rises

By Siddhi Mahatole and Padmanabhan Ananthan Sept 17 (Reuters) - U.S. health regulators will review the scientific evidence on testosterone use in menopausal women on Thursday, including its benefits, risks, dosing and role in female health, as well as perspectives from doctors and patients.
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U.S. Youth Caffeine Consumption Linked to Doubled Emergency Room Visits

U.S. Youth Caffeine Consumption Linked to Doubled Emergency Room Visits

A new report indicates a significant increase in caffeine-related emergency department visits among U.S. children aged 11 to 18, with numbers doubling between 2017 and 2024. Additionally, U.S. poison control centers recorded nearly 2,700 energy drink-related calls involving individuals aged 19 and under in 2023. The Centers for Disease Control and Prevention (CDC) reported that almost 63% of youth consumed caffeine daily between August 2021 and August 2023, with intake rising with age. Approximately one-third of those aged 12 to 17 regularly consume energy drinks. The report highlights that caffeine can mask the effects of alcohol, leading to higher rates of binge drinking, impaired driving, and alcohol-related injuries among college students who mix alcohol with energy drinks. While the U.S. Food and Drug Administration (FDA) suggests 400 milligrams of caffeine daily is generally safe for healthy adults, many energy drinks contain significantly higher amounts, and not all caffeine sources are required to ...
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Corbus Pharmaceuticals Announces New Obesity Drug CRB-913 with Fewer Side Effects Than GLP-1s

Corbus Pharmaceuticals Announces New Obesity Drug CRB-913 with Fewer Side Effects Than GLP-1s

Corbus Pharmaceuticals has announced promising results for its new anti-obesity drug, CRB-913, claiming it can achieve similar weight loss to GLP-1s with fewer gastrointestinal side effects. In a recent drug trial, CRB-913 demonstrated a 5% weight loss at a 60mg dose after 12 weeks. The drug is a CB1 inverse agonist, which works by reducing the influence of the CB1 receptor, thereby decreasing hunger signals. This mechanism differs from GLP-1 receptor agonists, which mimic the GLP-1 hormone. Previous attempts to target CB1 receptors for obesity treatment faced challenges due to psychiatric side effects, but Corbus Pharmaceuticals states that CRB-913 has minimal brain penetration, with psychiatric adverse events broadly in line with those experienced by GLP-1 users.
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Use of untested 'Wolverine' peptide backed by US Health Secretary Kennedy on the rise, study finds

Use of untested 'Wolverine' peptide backed by US Health Secretary Kennedy on the rise, study finds

By Nancy Lapid Sept 15 (Reuters) - An experimental peptide backed by U.S. Health Secretary Robert F.
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FDA Accepts Curi Bio's 3D Neuromuscular Junction Assay for ISTAND Program, Advancing Non-Animal Testing for Botulinum Toxin

FDA Accepts Curi Bio's 3D Neuromuscular Junction Assay for ISTAND Program, Advancing Non-Animal Testing for Botulinum Toxin

FDA Accepts Curi Bio's 3D Neuromuscular Junction Assay for ISTAND Program, Advancing Non-Animal Testing for Botulinum Toxin
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TwoStep Therapeutics Secures $62.5 Million Series A Funding and FDA Clearance for Cancer Drug

TwoStep Therapeutics Secures $62.5 Million Series A Funding and FDA Clearance for Cancer Drug

TwoStep Therapeutics Secures $62.5 Million Series A Funding and FDA Clearance for Cancer Drug
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Vyriad Initiates Phase 1 Clinical Trial for In Vivo CAR T Cell Therapy VV169 in Multiple Myeloma

Vyriad Initiates Phase 1 Clinical Trial for In Vivo CAR T Cell Therapy VV169 in Multiple Myeloma

Vyriad Initiates Phase 1 Clinical Trial for In Vivo CAR T Cell Therapy VV169 in Multiple Myeloma
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Rocket Pharmaceuticals Aligns with FDA on Pivotal Phase 2 Trial for Danon Disease Treatment

Rocket Pharmaceuticals Aligns with FDA on Pivotal Phase 2 Trial for Danon Disease Treatment

Rocket Pharmaceuticals Aligns with FDA on Pivotal Phase 2 Trial for Danon Disease Treatment