Antibody for Infant RSV Prevention to Face FDA Panel Nirsevimab shot also a possibility for some at-risk toddlers Jun 06, 2023
FDA Warns on Certain Forms of Compounded Semaglutide Some products may not contain the same active ingredient as the approved drugs Jun 01, 2023
FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancer Approval limited to BRCA-positive subset Jun 01, 2023
Second RSV Vaccine Lands Approval for Older Adults Abrysvo approved for adults 60 and up Jun 01, 2023
What Happens When We Classify Kids' Weight as a 'Disease'? The AAP obesity guidelines stand to worsen stigma and mental health May 27, 2023
Sotagliflozin Gets FDA's Blessing for Heart Failure SGLT1/SGLT2 inhibitor approved on the basis of SOLOIST-WHF, SCORED trials May 27, 2023
Tackling Barriers to OTC Birth Control Pills FDA approval would be a critical step, but we must address other access issues May 23, 2023
New Type of Opioid Reversal Agent Approved Longer-acting nasal spray to be available by end of the year May 23, 2023
Ocaliva for NASH Gets Thumbs Down From FDA Advisors Difficulty of risk mitigation for potential drug-induced liver injury weighed heavily on members May 19, 2023
Rare Skin Blistering Condition Gets First Drug Approved FDA's decision marks first approval for a redosable gene therapy May 19, 2023
FDA 'Leans In' to Accelerated Approval for Rare Disease Drugs CBER director says "moment is tender for gene therapy," sees opportunity to "salvage" treatments May 19, 2023
Should FDA Grant Accelerated Approval to Duchenne Muscular Dystrophy Gene Therapy? Waiting for the results of the SRP-9001 confirmatory trial may be a better move May 18, 2023
First JAK Inhibitor Approved for Crohn's Disease Upadacitinib lands indication for moderately to severely active disease in adults May 18, 2023
NASH Drug Candidate Comes With 'Serious Risks,' Says FDA Staff Agency reviewers signal little support for first potential nonalcoholic steatohepatitis drug May 17, 2023
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
