Tag: #FDA

After One Baby’s Custom CRISPR Rescue, a Startup Bets on Made-to-Order Gene Editing

A one-off CRISPR therapy saved a baby with a lethal mutation. Now a Doudna-backed startup and a new FDA pathway aim to scale bespoke gene medicines.

#crispr, #geneediting, #rarediseases, #fda, #biotech

FDA Approves First New Oral Gonorrhea Treatments in Decades, Offering Alternatives to the Standard Shot

The FDA approved two first-in-class oral antibiotics for uncomplicated gonorrhea, a long-awaited option as resistance threatens the standard ceftriaxone injection.

#gonorrhea, #antibiotics, #fda, #stis, #drugresistance

FDA-Approved Wegovy Pill Rolls Out Nationwide, Offering Daily Alternative to Weekly Injections

Novo Nordisk says its once-daily Wegovy tablet is now widely available in the U.S., with lower self-pay prices but strict dosing rules and coverage gaps.

#wegovy, #glp1, #obesity, #cardiovascular, #fda

FDA-Authorized Trial Tests Gene-Edited Pig Kidney Transplants in Living Patients

NYU Langone performs first transplant in an FDA-regulated trial of a gene-edited pig kidney, a step toward approval amid organ shortages.

#xenotransplantation, #kidneytransplant, #fda, #geneticengineering, #organshortage

Botulism Outbreak Linked to ByHeart Infant Formula Hospitalizes 51 Infants

51 infants hospitalized due to botulism linked to ByHeart infant formula, marking a public health first in the U.S.

#botulism, #infantformula, #cdc, #fda, #publichealth

Salmonella Outbreak Linked to Moringa Leaf Powder Prompts Nationwide Recall

Moringa leaf powder linked to Salmonella outbreak; product recalls initiated across 7 states.

#salmonella, #moringa, #health, #recall, #fda

Salmonella Outbreak Traced to Moringa Leaf Powder in Supplements

A 2025 Salmonella outbreak linked to moringa supplements prompts recalls across seven U.S. states.

#salmonella, #moringa, #fda, #cdc, #recall

FDA Approves New RSV Prevention for Infants: Merck's Enflonsia

FDA approves Merck's Enflonsia for RSV prevention in infants. New treatment reduces hospitalizations, boosts health equity.

#FDA, #rsv, #infanthealth, #mericenflonsia, #vaccines

FDA and CDC Shift COVID-19 Vaccine Policies, Focusing on High-Risk Groups

FDA and CDC limit COVID-19 vaccine recommendations to high-risk groups, altering access for millions.

#covid19, #vaccines, #fda, #cdc, #publichealth

FDA Approves Journavx: A New Non-Opioid Pain Medication

Journavx, a novel pain medication by Vertex, is FDA approved, marking a breakthrough in non-opioid pain management.

#fda, #painmanagement, #opioidcrisis, #vertexpharmaceuticals

Neuralink's Breakthrough: FDA Greenlights Human Trials for 'Blindsight' Implant

Neuralink gains FDA support for its Blindsight implant, a device aiming to restore vision in the blind, set to begin human trials by 2026.

#neuralink, #fda, #blindsight, #neurotechnology, #elonmusk

AAFP and FDA Diverge on COVID-19 Vaccination Guidelines

AAFP's broad COVID-19 vaccine recommendations contrast with FDA's restrictive guidelines, leading to public confusion.

#health, #vaccination, #covid19, #aafp, #fda

FDA Approves First Nasal Spray Flu Vaccine for At-Home Use

FluMist nasal spray gets FDA nod for home use, boosting influenza prevention access.

#FluMist, #FDA, #vaccines, #publichealth, #AstraZeneca

FDA Mandates New Opioid Labeling to Address Long-Term Use Risks

FDA orders new safety labels for opioids, highlighting risks of misuse and addiction after extensive data review.

#fda, #opioids, #health, #addiction, #publichealth

FDA Mandates New Opioid Labels to Highlight Risks of Addiction and Overdose

FDA updates opioid labels to emphasize long-term risks, enhancing public awareness and safety in prescribing practices.

#fda, #opioids, #health, #addiction, #overdose