<ѻýҕl>Bill to Study Xylazine Passes House, Advances in Senateѻýҕl> Measure does not address scheduling the drug, which is frequently added to fentanyl May 12, 2023
<ѻýҕl>FDA Updates Warnings on All Stimulants for ADHD, Other Conditionsѻýҕl> New language emphasizes potential for misuse, abuse, addiction, and overdose May 12, 2023
<ѻýҕl>FDA Panel Backs Needle-Free Epinephrine for Anaphylaxisѻýҕl> Choice of alternative route with nasal spray outweighs possible risks, panelists say May 12, 2023
<ѻýҕl>FDA Relaxes Blood Donation Rules for Gay and Bisexual Menѻýҕl> New guidance ditches MSM-specific screening questions in effort to expand eligibility May 11, 2023
<ѻýҕl>FDA OKs First Drug for Agitation in Alzheimer's Dementiaѻýҕl> Boxed warning on increased mortality risk in elderly patients remains for brexpiprazole May 11, 2023
<ѻýҕl>Sarepta's Duchenne Gene Therapy Does Not Have 'Unambiguous Evidence,' FDA Staff Saysѻýҕl> Agency reviewers question micro-dystrophin as a surrogate endpoint May 10, 2023
<ѻýҕl>FDA Staff Grapples With Absent Clinical Efficacy Data for Nasal Epinephrineѻýҕl> No precedent for approval of noninjectable epinephrine for anaphylaxis, noted agency reviewers May 10, 2023
<ѻýҕl>Proposed Breast Cancer Screening Guidelines Are Good, but Not Enoughѻýҕl> Specifics for older women, Black women, and those with dense breasts are needed May 09, 2023
<ѻýҕl>FDA Reviewers Raise Multiple Issues on OTC Birth Control Pillѻýҕl> Is labeling enough for users to take the drug correctly and self-deselect? May 05, 2023
<ѻýҕl>Forging the Path to a West Nile Vaccineѻýҕl> Alternative approaches to licensure are key, says CDC's Carolyn Gould May 04, 2023 video
<ѻýҕl>Why Is One Dose Suddenly Enough for the mRNA COVID Vaccines?ѻýҕl> FDA and CDC have made yet another questionable decision May 02, 2023
<ѻýҕl>FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPCѻýҕl> ODAC votes that olaparib-abiraterone combination should be restricted to BRCA-positive subset Apr 28, 2023
<ѻýҕl>Patients Living With Long COVID Offer Insight to FDAѻýҕl> Agency sought feedback on outcomes that matter most to patients Apr 28, 2023
<ѻýҕl>FDA Extends Trikafta Approval to Even Younger Cystic Fibrosis Patientsѻýҕl> Patients ages 2 to 5 years now eligible for the triple therapy Apr 27, 2023
<ѻýҕl>FDA OKs First Poop-Based Oral Therapyѻýҕl> Vowst approved for preventing recurrent C. difficile infections after antibiotics Apr 27, 2023
<ѻýҕl>Be Wary of Amniotic Fluid Eye Drops, FDA Saysѻýҕl> Agency sends another salvo in battle with birth-tissue industry Apr 24, 2023
<ѻýҕl>FDA Finally OKs Latest MiniMed System for Type 1 Diabetesѻýҕl> 780G system first to feature meal detection technology Apr 24, 2023
<ѻýҕl>Thumbs Down From FDA Panel on Plastic Meniscus Replacementѻýҕl> Members unimpressed with efficacy, safety data Apr 21, 2023
<ѻýҕl>Who Are the Doctors Suing FDA Over the Abortion Pill?ѻýҕl> Four physicians are named as plaintiffs alongside the Alliance for Hippocratic Medicine Apr 20, 2023
<ѻýҕl>FDA Panelists Slam Agency's Proposed Opioid Trial Designѻýҕl> Advisors said outcomes from an enriched enrollment study would not be broadly generalizable Apr 20, 2023
<ѻýҕl>Antibody-Drug Conjugate Gets FDA Thumbs Up for Untreated DLBCLѻýҕl> Adding polatuzumab vedotin to a modified version of R-CHOP significantly improved PFS Apr 20, 2023
<ѻýҕl>FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Painѻýҕl> Agency advisors will consider pros, cons of an enriched enrollment randomized withdrawal design Apr 17, 2023
<ѻýҕl>FDA Advisors Endorse Rexulti for Agitation in Alzheimer's Dementiaѻýҕl> Increased mortality risk seen but benefits may outweigh this, panelists say Apr 14, 2023
<ѻýҕl>FDA Panel to Weigh Limited Data on Combo for Healthcare-Acquired Pneumoniaѻýҕl> Sulbactam-durlobactam under consideration for cases caused by Acinetobacter spp. Apr 14, 2023
<ѻýҕl>All Opioid Pain Meds to Get New Safety Warnings, FDA Saysѻýҕl> Updated labeling to include warning about opioid-induced hyperalgesia Apr 13, 2023
<ѻýҕl>Rexulti Works for Agitation in Alzheimer's, Despite Risks, Says FDA Staffѻýҕl> Increased mortality risk consistent with other antipsychotics in elderly dementia patients Apr 13, 2023
<ѻýҕl>Reworked Philips CPAP, BiPAP Machines May Not Deliver Correct Therapyѻýҕl> And some of the remediated breathing devices may not provide any treatment at all, FDA warns Apr 10, 2023
<ѻýҕl>FDA Approval Authority in Jeopardy? TB Hits the Casino; Sen. Blumenthal's Surgeryѻýҕl> Health news and commentary from around the Web gathered by ѻýҕl staff Apr 10, 2023
<ѻýҕl>FDA Yanks Only Preterm Birth Drug, Effective Immediatelyѻýҕl> Months after advisors recommended Makena's approval be withdrawn, FDA announces final decision Apr 06, 2023
<ѻýҕl>Mail-Back Envelopes Will Be Dispensed With Outpatient Opioid Scriptsѻýҕl> Strategy will provide another option to dispose of unneeded medications, FDA says Apr 03, 2023
<ѻýҕl>Do Away With 'Lockout' Period in iPLEDGE, FDA Advisors Urgeѻýҕl> It's an "unduly high burden" on patients, says one advisory committee member Mar 29, 2023
<ѻýҕl>Isotretinoin REMS Still Needed, but Its Burden Could Be Reduced, FDA Staff Saysѻýҕl> Report suggests ways to lighten documentation rules for prescribing the severe acne treatment Mar 27, 2023
<ѻýҕl>FDA Greenlights First Drug for Rare Immunodeficiency Diseaseѻýҕl> Activated PI3K-delta syndrome may have a new standard of care Mar 27, 2023
<ѻýҕl>FDA Faults Next-Gen Olympus Duodenoscopesѻýҕl> After demanding single-use devices, agency finds they have their own problems Mar 27, 2023
<ѻýҕl>FDA: Watch for Joint Replacement Device Failure After Exactech Recallѻýҕl> Revision surgery only recommended for patients with pain Mar 23, 2023
<ѻýҕl>FDA Panel Supports Tofersen for Rare Genetic ALSѻýҕl> In a first, agency advisors back neurofilament light as a surrogate endpoint Mar 23, 2023
<ѻýҕl>FDA OKs Another PD-1 Inhibitor for Merkel Cell Carcinomaѻýҕl> Retifanlimab produced responses in 52% of patients with untreated unresectable disease Mar 22, 2023
<ѻýҕl>FDA Has Neglected Clinical Trial Transparency — Plus $45 Billion in Finesѻýҕl> It's time for more aggressive enforcement of the law Mar 21, 2023
<ѻýҕl>Investigational ALS Drug May Have Clinical Benefit, FDA Staff Saysѻýҕl> Neurofilament light will be evaluated as a surrogate endpoint in tofersen review Mar 20, 2023
<ѻýҕl>FDA Allows Lower Risk Designation for Snuff Productѻýҕl> The brand joins a limited few granted modified risk tobacco claims Mar 16, 2023