The Broader Significance of a New Drug for a Rare Form of ALS The tofersen trial offers hope and lessons for the fight against ALS May 15, 2023
Duchenne Muscular Dystrophy Treatment Narrowly Captures Support of FDA Advisors Whether vote means FDA will approve Sarepta's gene therapy remains to be seen May 13, 2023
FDA OKs Hormone-Free Pill for Hot Flashes First-in-class drug works by blocking the NK3 receptor, which plays role in regulating body temp May 12, 2023
Bill to Study Xylazine Passes House, Advances in Senate Measure does not address scheduling the drug, which is frequently added to fentanyl May 12, 2023
FDA Updates Warnings on All Stimulants for ADHD, Other Conditions New language emphasizes potential for misuse, abuse, addiction, and overdose May 12, 2023
FDA Panel Backs Needle-Free Epinephrine for Anaphylaxis Choice of alternative route with nasal spray outweighs possible risks, panelists say May 12, 2023
FDA Relaxes Blood Donation Rules for Gay and Bisexual Men New guidance ditches MSM-specific screening questions in effort to expand eligibility May 11, 2023
FDA OKs First Drug for Agitation in Alzheimer's Dementia Boxed warning on increased mortality risk in elderly patients remains for brexpiprazole May 11, 2023
Sarepta's Duchenne Gene Therapy Does Not Have 'Unambiguous Evidence,' FDA Staff Says Agency reviewers question micro-dystrophin as a surrogate endpoint May 10, 2023
FDA Staff Grapples With Absent Clinical Efficacy Data for Nasal Epinephrine No precedent for approval of noninjectable epinephrine for anaphylaxis, noted agency reviewers May 10, 2023
Proposed Breast Cancer Screening Guidelines Are Good, but Not Enough Specifics for older women, Black women, and those with dense breasts are needed May 09, 2023
FDA Reviewers Raise Multiple Issues on OTC Birth Control Pill Is labeling enough for users to take the drug correctly and self-deselect? May 05, 2023
Forging the Path to a West Nile Vaccine Alternative approaches to licensure are key, says CDC's Carolyn Gould May 04, 2023 video
Why Is One Dose Suddenly Enough for the mRNA COVID Vaccines? FDA and CDC have made yet another questionable decision May 02, 2023
FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPC ODAC votes that olaparib-abiraterone combination should be restricted to BRCA-positive subset Apr 28, 2023
Patients Living With Long COVID Offer Insight to FDA Agency sought feedback on outcomes that matter most to patients Apr 28, 2023
FDA Extends Trikafta Approval to Even Younger Cystic Fibrosis Patients Patients ages 2 to 5 years now eligible for the triple therapy Apr 27, 2023
FDA OKs First Poop-Based Oral Therapy Vowst approved for preventing recurrent C. difficile infections after antibiotics Apr 27, 2023
Be Wary of Amniotic Fluid Eye Drops, FDA Says Agency sends another salvo in battle with birth-tissue industry Apr 24, 2023
FDA Finally OKs Latest MiniMed System for Type 1 Diabetes 780G system first to feature meal detection technology Apr 24, 2023
Thumbs Down From FDA Panel on Plastic Meniscus Replacement Members unimpressed with efficacy, safety data Apr 21, 2023
Who Are the Doctors Suing FDA Over the Abortion Pill? Four physicians are named as plaintiffs alongside the Alliance for Hippocratic Medicine Apr 20, 2023
FDA Panelists Slam Agency's Proposed Opioid Trial Design Advisors said outcomes from an enriched enrollment study would not be broadly generalizable Apr 20, 2023
Antibody-Drug Conjugate Gets FDA Thumbs Up for Untreated DLBCL Adding polatuzumab vedotin to a modified version of R-CHOP significantly improved PFS Apr 20, 2023
FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain Agency advisors will consider pros, cons of an enriched enrollment randomized withdrawal design Apr 17, 2023
FDA Advisors Endorse Rexulti for Agitation in Alzheimer's Dementia Increased mortality risk seen but benefits may outweigh this, panelists say Apr 14, 2023
FDA Panel to Weigh Limited Data on Combo for Healthcare-Acquired Pneumonia Sulbactam-durlobactam under consideration for cases caused by Acinetobacter spp. Apr 14, 2023
All Opioid Pain Meds to Get New Safety Warnings, FDA Says Updated labeling to include warning about opioid-induced hyperalgesia Apr 13, 2023
Rexulti Works for Agitation in Alzheimer's, Despite Risks, Says FDA Staff Increased mortality risk consistent with other antipsychotics in elderly dementia patients Apr 13, 2023
Reworked Philips CPAP, BiPAP Machines May Not Deliver Correct Therapy And some of the remediated breathing devices may not provide any treatment at all, FDA warns Apr 10, 2023
FDA Approval Authority in Jeopardy? TB Hits the Casino; Sen. Blumenthal's Surgery Health news and commentary from around the Web gathered by ľ¹ÏÖ±²¥ staff Apr 10, 2023
FDA Yanks Only Preterm Birth Drug, Effective Immediately Months after advisors recommended Makena's approval be withdrawn, FDA announces final decision Apr 06, 2023
Mail-Back Envelopes Will Be Dispensed With Outpatient Opioid Scripts Strategy will provide another option to dispose of unneeded medications, FDA says Apr 03, 2023
Do Away With 'Lockout' Period in iPLEDGE, FDA Advisors Urge It's an "unduly high burden" on patients, says one advisory committee member Mar 29, 2023
Isotretinoin REMS Still Needed, but Its Burden Could Be Reduced, FDA Staff Says Report suggests ways to lighten documentation rules for prescribing the severe acne treatment Mar 27, 2023
FDA Greenlights First Drug for Rare Immunodeficiency Disease Activated PI3K-delta syndrome may have a new standard of care Mar 27, 2023
FDA Faults Next-Gen Olympus Duodenoscopes After demanding single-use devices, agency finds they have their own problems Mar 27, 2023
FDA: Watch for Joint Replacement Device Failure After Exactech Recall Revision surgery only recommended for patients with pain Mar 23, 2023
FDA Panel Supports Tofersen for Rare Genetic ALS In a first, agency advisors back neurofilament light as a surrogate endpoint Mar 23, 2023
FDA OKs Another PD-1 Inhibitor for Merkel Cell Carcinoma Retifanlimab produced responses in 52% of patients with untreated unresectable disease Mar 22, 2023
