Impella Devices Recalled After Deaths, Injuries Tied to TAVR Interactions Recall involves new instructions for use without devices needing to be returned Jul 28, 2023
FDA Warns Company Over Amniotic Products Agency says Cell Genuity products should be regulated as a drug Jul 27, 2023
First Treatment for Demodex Blepharitis Wins FDA Approval Lotilaner ophthalmic solution reduced eyelash collarettes, increased mite eradication Jul 26, 2023
DOJ Goes After PA for Amniotic Fluid Injections Prosecutors called shots a "dubious attempt at pain management" Jul 25, 2023
First Treatment Approved for Molluscum Contagiosum Half of patients across two randomized trials had complete clearance of lesions Jul 24, 2023
FDA Strikes at Yet Another Birth Tissue Company Agency sent warning letter to Regenative Labs over its Wharton's jelly product Jul 19, 2023
New Drug Approved for Preventing RSV in Newborns, Tots Nirsevimab indicated for all infants, and for kids up to 2 years at high risk Jul 17, 2023
Registry Enrollment for Alzheimer's Drug Coverage Won't Help Much A minimalist policy for a minimalist treatment Jul 11, 2023
FDA Appears to Mostly Follow Its Drug Advisory Committees' Advice "Pro-approval bias" suggests committees are used to identify barriers to approval, expert argues Jul 07, 2023
Psychedelic Research: Experts React to FDA Draft Guidance Feedback is mostly positive, but concerns arise around two-monitor recommendation Jul 06, 2023
First Dual-Chamber Leadless Pacemaker Approved by FDA System comprises two small leadless pacemakers communicating wirelessly Jul 05, 2023
First Cellular Therapy Approved for Type 1 Diabetes Infusion made from deceased donor pancreatic islet cells Jun 29, 2023
FDA Greenlights New Myasthenia Gravis Drug First therapy approved for anti-AChR-positive and anti-MuSK antibody-positive patients Jun 27, 2023
FDA Staff Weighs 'Alternative' Data on Retinoid for Rare Bone Disorder Challenges of drug development in fibrodysplasia ossificans progressiva on full display Jun 27, 2023
Without Early Detection, Fighting Dementia Is an Uphill Battle A brief assessment in primary care can help identify patients most at risk Jun 27, 2023
First Oral JAK Inhibitor Approved for Severe Alopecia Areata in Teens Ritlecitinib led to 80% scalp coverage at 6 months in nearly a fourth of adolescents and adults Jun 26, 2023
Our Health Systems Aren't Ready for the Full Approval of Lecanemab Screening, administration, and eligibility concerns remain Jun 23, 2023
Controversial Gene Therapy Wins FDA Approval for Duchenne Muscular Dystrophy Sarepta's treatment gets a nod for ambulatory pediatric patients Jun 22, 2023
Another Online SARMs Retailer Gets a Warning From the FDA Warrior Labz SARMS markets several drugs they claim could address weight loss, muscle growth Jun 22, 2023
First SGLT2 Inhibitor Approved for Kids With Type 2 Diabetes Now another oral option other than metformin Jun 21, 2023
Colchicine's Rebirth as Cardiovascular Drug Approved by FDA Repurposed anti-inflammatory drug may be used alone or in combination with standard meds Jun 20, 2023
New Bispecific Antibody Approved for Tough-to-Treat Lymphoma Approval of glofitamab was based on a phase I/II study that showed a 56% overall response rate Jun 16, 2023
Alzheimer's Drug Clears Major Hurdle Toward Full Approval But risks associated with anti-amyloid agent lecanemab still loom Jun 09, 2023
Did FDA Apply Rigorous Standards in Approving Paxlovid? Evidence for all relevant studies should be accessible Jun 09, 2023
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