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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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Pennsylvania measles-associated deaths climb to four as outbreak grows

Pennsylvania measles-associated deaths climb to four as outbreak grows

By Sriparna Roy and Kamal Choudhury Sept 15 (Reuters) - The Pennsylvania Department of Health on Tuesday reported two more measles-associated deaths, both in unvaccinated individuals, bringing the state's total fatalities linked to the disease outbreak to four.
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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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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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CDC delay holds up children's COVID vaccine orders, WSJ reports

CDC delay holds up children's COVID vaccine orders, WSJ reports

Sept 16 (Reuters) - U.S. states are facing delays in obtaining COVID-19 vaccines for children through a federal immunization program, the Wall Street Journal reported Wednesday, citing people familiar with the matter. The U.S.
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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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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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Dollarama raises annual sales forecast in Canada as cost-conscious shoppers trade down

Dollarama raises annual sales forecast in Canada as cost-conscious shoppers trade down

By Shania S Thomas Sept 16 (Reuters) - Canada's Dollarama raised annual comparable sales growth forecast on Wednesday, as shoppers opt for its cheaper everyday products while contending with higher costs of living and trade-related uncertainty.
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Experts urge FDA to set clear safety and access standards for psychedelic drugs

Experts urge FDA to set clear safety and access standards for psychedelic drugs

By Puyaan Singh and Kamal Choudhury Sept 14 (Reuters) - Doctors, veterans, pharmacists and therapists on Monday urged the U.S.
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FDA holds public hearing on psychedelic drugs as Trump-driven push gathers pace

FDA holds public hearing on psychedelic drugs as Trump-driven push gathers pace

By Puyaan Singh and Kamal Choudhury Sept 14 (Reuters) - The U.S.
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FDA Expands Joenja Approval to Children Aged 4 to 11 Years with APDS

FDA Expands Joenja Approval to Children Aged 4 to 11 Years with APDS

The U.S. Food and Drug Administration (FDA) has expanded the approval of Joenja (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) to include children aged 4 to 11 years who weigh at least 27kg. This new approval builds upon the existing authorization for patients aged 12 years and older. APDS is a rare primary immunodeficiency caused by genetic variants in the PIK3CD or PIK3R1 genes, which are crucial for immune cell function. These variants lead to the overactivation of the PI3Kδ pathway, resulting in immunodeficiency and dysregulation. Joenja is an oral, small molecule PI3Kδ inhibitor designed to target this pathway. The FDA's decision was supported by data from a single-arm, phase 3 study involving 8 patients in the 4 to 11 age group, which showed consistent pharmacokinetic and safety profiles compared to older patients. The approval also introduces new 40mg and 50mg tablet strengths to accommodate pediatric dosing based on body weight.
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Pennsylvania reports two additional measles-associated deaths

Pennsylvania reports two additional measles-associated deaths

Sept 15 (Reuters) - The Pennsylvania Department of Health on Tuesday confirmed two more measles-associated deaths, both in unvaccinated individuals, bringing the state's total fatalities linked to the disease to four.