<ѻý>FDA Updates Warnings on All Stimulants for ADHD, Other Conditionsѻý> New language emphasizes potential for misuse, abuse, addiction, and overdose May 12, 2023
<ѻý>FDA Panel Backs Needle-Free Epinephrine for Anaphylaxisѻý> Choice of alternative route with nasal spray outweighs possible risks, panelists say May 12, 2023
<ѻý>FDA Relaxes Blood Donation Rules for Gay and Bisexual Menѻý> New guidance ditches MSM-specific screening questions in effort to expand eligibility May 11, 2023
<ѻý>Senators Call Out PBMs, Drugmakers for High Prescription Drug Costsѻý> This "is a moral issue," Sen. Bernie Sanders said during the hearing May 11, 2023
<ѻý>FDA OKs First Drug for Agitation in Alzheimer's Dementiaѻý> Boxed warning on increased mortality risk in elderly patients remains for brexpiprazole May 11, 2023
<ѻý>Sarepta's Duchenne Gene Therapy Does Not Have 'Unambiguous Evidence,' FDA Staff Saysѻý> Agency reviewers question micro-dystrophin as a surrogate endpoint May 10, 2023
<ѻý>As the COVID PHE Ends, Here's What Doctors Are Carrying Forwardѻý> Responses range the spectrum, from asking patients to mask, to not changing a thing May 10, 2023
<ѻý>FDA Staff Grapples With Absent Clinical Efficacy Data for Nasal Epinephrineѻý> No precedent for approval of noninjectable epinephrine for anaphylaxis, noted agency reviewers May 10, 2023
<ѻý>Proposed Breast Cancer Screening Guidelines Are Good, but Not Enoughѻý> Specifics for older women, Black women, and those with dense breasts are needed May 09, 2023
<ѻý>FDA Reviewers Raise Multiple Issues on OTC Birth Control Pillѻý> Is labeling enough for users to take the drug correctly and self-deselect? May 05, 2023
<ѻý>Democratic Senators Rebuke Cuts to NIH in House-Passed Billѻý> But lawmakers from both parties are "disappointed" with the president's budget proposal May 05, 2023
<ѻý>Forging the Path to a West Nile Vaccineѻý> Alternative approaches to licensure are key, says CDC's Carolyn Gould May 04, 2023 video
<ѻý>'Ghost' Provider Networks a Big Problem for Patients, Especially in Mental Healthѻý> Only 18% of docs called by Senate's "secret shoppers" were really in-network and taking patients May 03, 2023
<ѻý>Feds Spent Even More on PrEP Combo Than Previously Thoughtѻý> New estimate says taxpayers spent over $140 million to study Truvada as HIV prevention May 02, 2023
<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>Some Private Companies Charge Hefty Fees to Help Veterans With Disability Claimsѻý> Unaccredited operators cause headaches for vets Apr 30, 2023
<ѻý>It's a Precarious Path From Dreamer to Doctorѻý> DACA recipients face barriers to education and practice Apr 29, 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>ACOG PAC Donated Over $1M to Anti-Abortion Legislatorsѻý> Ob/gyn organization maintains stated support for reproductive healthcare, including abortion Apr 28, 2023
<ѻý>More Efforts Needed to Combat Antimicrobial Resistance, Lawmakers Toldѻý> Witnesses at House hearing push for new drugs and tests, and more infectious disease docs 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>Return of 3-Day Rule Will Stress Crowded Hospitals Furtherѻý> Groups call for the 57-year-old policy to be abolished Apr 26, 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>ADHD Drug Abuse in Schools; Bizarre Ozempic Dreams; COVID Ups Diabetes Riskѻý> Health news and commentary from around the Web gathered by ѻý staff Apr 19, 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>The Promise of the $5 Billion Investment in 'Project Next Gen'ѻý> Here's how to make it money well spent 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>NIH's Genome Chief Says Genomics Is Evolving and Docs Need More Education on Itѻý> National Human Genome Research Institute Director Eric Green sits down with ѻý Apr 07, 2023