<ѻýҕl>NASH Drug Candidate Comes With 'Serious Risks,' Says FDA Staffѻýҕl> Agency reviewers signal little support for first potential nonalcoholic steatohepatitis drug May 17, 2023
<ѻýҕl>The Broader Significance of a New Drug for a Rare Form of ALSѻýҕl> The tofersen trial offers hope and lessons for the fight against ALS May 15, 2023
<ѻýҕl>Duchenne Muscular Dystrophy Treatment Narrowly Captures Support of FDA Advisorsѻýҕl> Whether vote means FDA will approve Sarepta's gene therapy remains to be seen May 13, 2023
<ѻýҕl>FDA OKs Hormone-Free Pill for Hot Flashesѻýҕl> First-in-class drug works by blocking the NK3 receptor, which plays role in regulating body temp May 12, 2023
<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>Senators Call Out PBMs, Drugmakers for High Prescription Drug Costsѻýҕl> This "is a moral issue," Sen. Bernie Sanders said during the hearing 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>As the COVID PHE Ends, Here's What Doctors Are Carrying Forwardѻýҕl> Responses range the spectrum, from asking patients to mask, to not changing a thing 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>Democratic Senators Rebuke Cuts to NIH in House-Passed Billѻýҕl> But lawmakers from both parties are "disappointed" with the president's budget proposal 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>'Ghost' Provider Networks a Big Problem for Patients, Especially in Mental Healthѻýҕl> Only 18% of docs called by Senate's "secret shoppers" were really in-network and taking patients May 03, 2023
<ѻýҕl>Feds Spent Even More on PrEP Combo Than Previously Thoughtѻýҕl> New estimate says taxpayers spent over $140 million to study Truvada as HIV prevention May 02, 2023
<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>Some Private Companies Charge Hefty Fees to Help Veterans With Disability Claimsѻýҕl> Unaccredited operators cause headaches for vets Apr 30, 2023
<ѻýҕl>It's a Precarious Path From Dreamer to Doctorѻýҕl> DACA recipients face barriers to education and practice Apr 29, 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>ACOG PAC Donated Over $1M to Anti-Abortion Legislatorsѻýҕl> Ob/gyn organization maintains stated support for reproductive healthcare, including abortion Apr 28, 2023
<ѻýҕl>More Efforts Needed to Combat Antimicrobial Resistance, Lawmakers Toldѻýҕl> Witnesses at House hearing push for new drugs and tests, and more infectious disease docs 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>Return of 3-Day Rule Will Stress Crowded Hospitals Furtherѻýҕl> Groups call for the 57-year-old policy to be abolished Apr 26, 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>ADHD Drug Abuse in Schools; Bizarre Ozempic Dreams; COVID Ups Diabetes Riskѻýҕl> Health news and commentary from around the Web gathered by ѻýҕl staff Apr 19, 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