Tag: #fda

FDA Approves Updated COVID-19 Vaccines Targeting KP.2 Variant Amid Surge

FDA approves new COVID-19 vaccines for KP.2 variant amid U.S. surge, aligning with CDC guidance for enhanced protection.

#covid19, #vaccines, #fda, #health, #cdc

FDA Approves Neffy: First Needle-Free Nasal Spray for Severe Allergic Reactions

FDA approves Neffy, a needle-free nasal spray by ARS Pharmaceuticals for severe allergic reactions, offering an alternative to EpiPen.

#fda, #epinephrine, #allergies, #nasalspray

FDA Launches New Program to Expedite Drug Approvals

FDA introduces new program to fast-track drug approvals, reducing review times for crucial medications to just 1-2 months.

#fda, #pharmaceuticals, #drugapprovals, #healthcare

FDA Launches Commissioner's National Priority Voucher Program to Speed Drug Reviews

FDA's CNPV program to fast-track drug reviews, aligning with national health priorities. Launching in 2025 as a pilot.

#fda, #drugreview, #health, #pharmaceuticals

FDA Approves Eli Lilly’s Donanemab for Early-Stage Alzheimer’s Treatment

FDA approves Kisunla, offering new hope for early Alzheimer's patients with 29% slower cognitive decline.

#fda, #alzheimer, #donanemab, #healthcare

FDA Updates COVID-19 Vaccine Guidelines, Halts Routine Boosters for Healthy Adults Under 65

FDA ends routine COVID-19 boosters for healthy individuals under 65, emphasizing robust clinical trials for vaccine approval.

#fda, #covid19, #vaccines, #publichealth

FDA Panel to Evaluate COVID-19 Vaccine Strategy Amid Leadership Changes

FDA expert panel to convene under new leadership to assess COVID-19 vaccine plans, signaling potential shifts in public health policy.

#fda, #covid19, #vaccines, #publichealth

FDA Approves Blujepa: A New Class of Oral Antibiotic for Urinary Tract Infections

FDA greenlights Blujepa, the first new oral antibiotic for uUTIs in 30 years, targeting resistance with a novel dual enzyme mechanism.

#fda, #antibiotics, #urinary tract infections, #gsk, #healthcare

FDA's Dr. Peter Marks Resigns Amid Controversy Over Vaccine Misinformation

Dr. Peter Marks resigns as Director of the CBER at the FDA, citing Health and Human Services Secretary RFK Jr.'s vaccine misinformation. His departure highlights the clash between political appointments and scientific integrity.

#fda, #peter marks, #vaccine misinformation, #rfk jr, #health