FDA Advisers Reject Nuplazid for Alzheimer’s Disease Psychosis
An FDA advisory panel rejected pimavanserin (Nuplazid) for the treatment of hallucinations and delusions in patients with Alzheimer’s disease psychosis on Friday. In a vote of 9-3, the Psychopharmacologic Drugs Advisory Committee decided against recommending the drug for approval for these patients, citing a slew of shortcomings in supporting trial data. This could have been […]
FDA Panel Backs Pfizer, Moderna Shots for Kids 5 and Under – MedicineNet Health News
Latest Coronavirus News By Robin Foster HealthDay Reporter THURSDAY, June 16, 2022 An advisory panel to the U.S. Food and Drug Administration voted unanimously on Wednesday to recommend the emergency use of both the Pfizer and Moderna COVID-19 vaccines for the country’s youngest children. The approvals come not a moment too soon: More than two […]
COVID Toddler Vax Clears Major Hurdle
An advisory committee recommended that the FDA give emergency use authorization (EUA) to both Moderna and Pfizer/BioNTech’s mRNA COVID-19 vaccines for infants, toddlers, and preschool kids. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21-0 in favor of expanded access to each vaccine, in another unanimous decision that the benefits of the vaccines […]
Beta-Thalassemia Gene Tx Gets Ringing Endorsement From FDA Advisers
An FDA advisory committee on Friday unanimously recommended betibeglogene autotemcel (beti-cel) for approval in patients with transfusion-dependent beta-thalassemia, a chronic inherited blood disorder. With a 13-0 vote, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee said the benefits of the one-time, first-in-class lentiviral vector (LVV) gene therapy outweigh any of the risks associated with the […]
ALS Drug Needs More Evidence, FDA Advisors Say
In a close call, an FDA advisory committee said data from a single trial for AMX0035, an investigational agent being studied to treat amyotrophic lateral sclerosis (ALS), did not support a conclusion that the drug was effective. The 6-4 vote of the Peripheral and Central Nervous System Drugs Advisory Committee was based on findings from […]
CDC Panel: Thumbs Down on Pfizer Booster for Healthcare Workers
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted Thursday to unanimously recommend a booster dose of Pfizer’s COVID-19 vaccine (Comirnaty) for adults ages 65 and up and those in long-term care facilities, as well as for adults ages 50 to 64 with high-risk medical conditions (by a vote of 13-2), but that was where […]
FDA Panel Backs Pfizer Booster for Select Groups
An FDA advisory panel recommended emergency use authorization (EUA) of a booster dose of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) for individuals 65 and older, and those judged to be at high risk of severe COVID-19. On Friday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 18-0 that the known and potential benefits […]
Liver Toxicity in Gene Therapy Trials Could Merit Stricter Entry Criteria
An FDA advisory committee offered up lower vector doses, stricter exclusion criteria, and long-term animal studies to grapple with liver toxicities associated with adeno-associated virus (AAV) vector-based gene therapies. During the second of four sessions on AAV safety, the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) weighed evidence of hepatotoxicity — ranging from liver […]
Safety Concerns Turn FDA Panel Thumbs Down for Novel CKD-Anemia Drug
An FDA advisory committee almost unanimously agreed that the risks were just too high for the chronic kidney disease (CKD)-related anemia drug roxadustat in any patient population. In a 13-1 vote Thursday, members of the Cardiovascular and Renal Drugs Advisory Committee felt that although there’s an unmet need for new anemia therapeutics, this particular drug […]