<ѻý>Why Is One Dose Suddenly Enough for the mRNA COVID Vaccines?ѻý> FDA and CDC have made yet another questionable decision May 02, 2023
<ѻý>FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPCѻý> ODAC votes that olaparib-abiraterone combination should be restricted to BRCA-positive subset Apr 28, 2023
<ѻý>Patients Living With Long COVID Offer Insight to FDAѻý> Agency sought feedback on outcomes that matter most to patients Apr 28, 2023
<ѻý>FDA Extends Trikafta Approval to Even Younger Cystic Fibrosis Patientsѻý> Patients ages 2 to 5 years now eligible for the triple therapy Apr 27, 2023
<ѻý>FDA OKs First Poop-Based Oral Therapyѻý> Vowst approved for preventing recurrent C. difficile infections after antibiotics Apr 27, 2023
<ѻý>Be Wary of Amniotic Fluid Eye Drops, FDA Saysѻý> Agency sends another salvo in battle with birth-tissue industry Apr 24, 2023
<ѻý>FDA Finally OKs Latest MiniMed System for Type 1 Diabetesѻý> 780G system first to feature meal detection technology Apr 24, 2023
<ѻý>Thumbs Down From FDA Panel on Plastic Meniscus Replacementѻý> Members unimpressed with efficacy, safety data Apr 21, 2023
<ѻý>Who Are the Doctors Suing FDA Over the Abortion Pill?ѻý> Four physicians are named as plaintiffs alongside the Alliance for Hippocratic Medicine Apr 20, 2023
<ѻý>FDA Panelists Slam Agency's Proposed Opioid Trial Designѻý> Advisors said outcomes from an enriched enrollment study would not be broadly generalizable Apr 20, 2023
<ѻý>Antibody-Drug Conjugate Gets FDA Thumbs Up for Untreated DLBCLѻý> Adding polatuzumab vedotin to a modified version of R-CHOP significantly improved PFS Apr 20, 2023
<ѻý>FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Painѻý> Agency advisors will consider pros, cons of an enriched enrollment randomized withdrawal design Apr 17, 2023
<ѻý>FDA Advisors Endorse Rexulti for Agitation in Alzheimer's Dementiaѻý> Increased mortality risk seen but benefits may outweigh this, panelists say Apr 14, 2023
<ѻý>FDA Panel to Weigh Limited Data on Combo for Healthcare-Acquired Pneumoniaѻý> Sulbactam-durlobactam under consideration for cases caused by Acinetobacter spp. Apr 14, 2023
<ѻý>All Opioid Pain Meds to Get New Safety Warnings, FDA Saysѻý> Updated labeling to include warning about opioid-induced hyperalgesia Apr 13, 2023
<ѻý>Rexulti Works for Agitation in Alzheimer's, Despite Risks, Says FDA Staffѻý> Increased mortality risk consistent with other antipsychotics in elderly dementia patients Apr 13, 2023
<ѻý>Reworked Philips CPAP, BiPAP Machines May Not Deliver Correct Therapyѻý> And some of the remediated breathing devices may not provide any treatment at all, FDA warns Apr 10, 2023
<ѻý>FDA Approval Authority in Jeopardy? TB Hits the Casino; Sen. Blumenthal's Surgeryѻý> Health news and commentary from around the Web gathered by ѻý staff Apr 10, 2023
<ѻý>FDA Yanks Only Preterm Birth Drug, Effective Immediatelyѻý> Months after advisors recommended Makena's approval be withdrawn, FDA announces final decision Apr 06, 2023
<ѻý>Mail-Back Envelopes Will Be Dispensed With Outpatient Opioid Scriptsѻý> Strategy will provide another option to dispose of unneeded medications, FDA says Apr 03, 2023
<ѻý>Do Away With 'Lockout' Period in iPLEDGE, FDA Advisors Urgeѻý> It's an "unduly high burden" on patients, says one advisory committee member Mar 29, 2023
<ѻý>Isotretinoin REMS Still Needed, but Its Burden Could Be Reduced, FDA Staff Saysѻý> Report suggests ways to lighten documentation rules for prescribing the severe acne treatment Mar 27, 2023
<ѻý>FDA Greenlights First Drug for Rare Immunodeficiency Diseaseѻý> Activated PI3K-delta syndrome may have a new standard of care Mar 27, 2023
<ѻý>FDA Faults Next-Gen Olympus Duodenoscopesѻý> After demanding single-use devices, agency finds they have their own problems Mar 27, 2023
<ѻý>FDA: Watch for Joint Replacement Device Failure After Exactech Recallѻý> Revision surgery only recommended for patients with pain Mar 23, 2023
<ѻý>FDA Panel Supports Tofersen for Rare Genetic ALSѻý> In a first, agency advisors back neurofilament light as a surrogate endpoint Mar 23, 2023
<ѻý>FDA OKs Another PD-1 Inhibitor for Merkel Cell Carcinomaѻý> Retifanlimab produced responses in 52% of patients with untreated unresectable disease Mar 22, 2023
<ѻý>FDA Has Neglected Clinical Trial Transparency — Plus $45 Billion in Finesѻý> It's time for more aggressive enforcement of the law Mar 21, 2023
<ѻý>Investigational ALS Drug May Have Clinical Benefit, FDA Staff Saysѻý> Neurofilament light will be evaluated as a surrogate endpoint in tofersen review Mar 20, 2023
<ѻý>FDA Allows Lower Risk Designation for Snuff Productѻý> The brand joins a limited few granted modified risk tobacco claims Mar 16, 2023
<ѻý>CDC, FDA Heads Fire Back at Ladapo Letterѻý> Califf and Walensky say Florida Surgeon General's VAERS analysis is "incorrect, misleading" Mar 13, 2023
<ѻý>FDA Panel Endorses New First-Line Lymphoma Regimenѻý> POLARIX trial supports a favorable risk-benefit profile for polatuzumab vedotin, ODAC members say Mar 10, 2023
<ѻý>First Bimodal Neuromodulation Device for Tinnitus Gets FDA Nodѻý> Ringing ears may get relief with sound and tongue stimulation Mar 08, 2023
<ѻý>Only Drug to Prevent Preterm Birth Set to Leave the Marketѻý> Decision follows FDA advisory committee recommendation for withdrawal Mar 08, 2023
<ѻý>FDA Not Quite Sold on Polivy in Frontline Large B-Cell Lymphoma Regimenѻý> Ahead of ODAC meeting, agency reviewers suggest modest PFS results in POLARIX "raise uncertainty" Mar 07, 2023
<ѻý>FDA Mandate on Acetaminophen-Opioid Combinations Appeared Effectiveѻý> Hospitalizations for liver toxicity declined after FDA limited acetaminophen dose Mar 07, 2023
<ѻý>First Treatment Approved for Rare Neurodegenerative Disorderѻý> Omaveloxolone gets FDA nod for Friedreich's ataxia Mar 01, 2023
<ѻý>Omecamtiv Mecarbil for Heart Failure Turned Down by FDAѻý> End of the road for cardiac myosin activator Mar 01, 2023
<ѻý>FDA Issues Import Alert on 'Tranq' Drug Xylazineѻý> Drug will be under added scrutiny to make sure it's for "legitimate veterinary use," agency says Feb 28, 2023
<ѻý>A Ban on the Abortion Drug Mifepristone Is Loomingѻý> A Texas lawsuit may be disastrous for effective abortion access and FDA's authority Feb 23, 2023