<ѻýҕl>First Treatment for Demodex Blepharitis Wins FDA Approvalѻýҕl> Lotilaner ophthalmic solution reduced eyelash collarettes, increased mite eradication Jul 26, 2023
<ѻýҕl>DOJ Goes After PA for Amniotic Fluid Injectionsѻýҕl> Prosecutors called shots a "dubious attempt at pain management" Jul 25, 2023
<ѻýҕl>First Treatment Approved for Molluscum Contagiosumѻýҕl> Half of patients across two randomized trials had complete clearance of lesions Jul 24, 2023
<ѻýҕl>FDA Strikes at Yet Another Birth Tissue Companyѻýҕl> Agency sent warning letter to Regenative Labs over its Wharton's jelly product Jul 19, 2023
<ѻýҕl>New Drug Approved for Preventing RSV in Newborns, Totsѻýҕl> Nirsevimab indicated for all infants, and for kids up to 2 years at high risk Jul 17, 2023
<ѻýҕl>Registry Enrollment for Alzheimer's Drug Coverage Won't Help Muchѻýҕl> A minimalist policy for a minimalist treatment Jul 11, 2023
<ѻýҕl>FDA Appears to Mostly Follow Its Drug Advisory Committees' Adviceѻýҕl> "Pro-approval bias" suggests committees are used to identify barriers to approval, expert argues Jul 07, 2023
<ѻýҕl>Alzheimer's Drug Wins Full FDA Approvalѻýҕl> Decision expands lecanemab's Medicare coverage Jul 06, 2023
<ѻýҕl>Psychedelic Research: Experts React to FDA Draft Guidanceѻýҕl> Feedback is mostly positive, but concerns arise around two-monitor recommendation Jul 06, 2023
<ѻýҕl>First Dual-Chamber Leadless Pacemaker Approved by FDAѻýҕl> System comprises two small leadless pacemakers communicating wirelessly Jul 05, 2023
<ѻýҕl>First Cellular Therapy Approved for Type 1 Diabetesѻýҕl> Infusion made from deceased donor pancreatic islet cells Jun 29, 2023
<ѻýҕl>FDA Greenlights New Myasthenia Gravis Drugѻýҕl> First therapy approved for anti-AChR-positive and anti-MuSK antibody-positive patients Jun 27, 2023
<ѻýҕl>FDA Staff Weighs 'Alternative' Data on Retinoid for Rare Bone Disorderѻýҕl> Challenges of drug development in fibrodysplasia ossificans progressiva on full display Jun 27, 2023
<ѻýҕl>Without Early Detection, Fighting Dementia Is an Uphill Battleѻýҕl> A brief assessment in primary care can help identify patients most at risk Jun 27, 2023
<ѻýҕl>First Oral JAK Inhibitor Approved for Severe Alopecia Areata in Teensѻýҕl> Ritlecitinib led to 80% scalp coverage at 6 months in nearly a fourth of adolescents and adults Jun 26, 2023
<ѻýҕl>Our Health Systems Aren't Ready for the Full Approval of Lecanemabѻýҕl> Screening, administration, and eligibility concerns remain Jun 23, 2023
<ѻýҕl>Controversial Gene Therapy Wins FDA Approval for Duchenne Muscular Dystrophyѻýҕl> Sarepta's treatment gets a nod for ambulatory pediatric patients Jun 22, 2023
<ѻýҕl>Another Online SARMs Retailer Gets a Warning From the FDAѻýҕl> Warrior Labz SARMS markets several drugs they claim could address weight loss, muscle growth Jun 22, 2023
<ѻýҕl>First SGLT2 Inhibitor Approved for Kids With Type 2 Diabetesѻýҕl> Now another oral option other than metformin Jun 21, 2023
<ѻýҕl>Colchicine's Rebirth as Cardiovascular Drug Approved by FDAѻýҕl> Repurposed anti-inflammatory drug may be used alone or in combination with standard meds Jun 20, 2023
<ѻýҕl>New Bispecific Antibody Approved for Tough-to-Treat Lymphomaѻýҕl> Approval of glofitamab was based on a phase I/II study that showed a 56% overall response rate Jun 16, 2023
<ѻýҕl>Alzheimer's Drug Clears Major Hurdle Toward Full Approvalѻýҕl> But risks associated with anti-amyloid agent lecanemab still loom Jun 09, 2023
<ѻýҕl>Did FDA Apply Rigorous Standards in Approving Paxlovid?ѻýҕl> Evidence for all relevant studies should be accessible Jun 09, 2023
<ѻýҕl>Antibody for Infant RSV Prevention to Face FDA Panelѻýҕl> Nirsevimab shot also a possibility for some at-risk toddlers Jun 06, 2023
<ѻýҕl>FDA Warns on Certain Forms of Compounded Semaglutideѻýҕl> Some products may not contain the same active ingredient as the approved drugs Jun 01, 2023
<ѻýҕl>FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancerѻýҕl> Approval limited to BRCA-positive subset Jun 01, 2023
<ѻýҕl>Second RSV Vaccine Lands Approval for Older Adultsѻýҕl> Abrysvo approved for adults 60 and up Jun 01, 2023
<ѻýҕl>What Happens When We Classify Kids' Weight as a 'Disease'?ѻýҕl> The AAP obesity guidelines stand to worsen stigma and mental health May 27, 2023
<ѻýҕl>Sotagliflozin Gets FDA's Blessing for Heart Failureѻýҕl> SGLT1/SGLT2 inhibitor approved on the basis of SOLOIST-WHF, SCORED trials May 27, 2023
<ѻýҕl>Tackling Barriers to OTC Birth Control Pillsѻýҕl> FDA approval would be a critical step, but we must address other access issues May 23, 2023
<ѻýҕl>New Type of Opioid Reversal Agent Approvedѻýҕl> Longer-acting nasal spray to be available by end of the year May 23, 2023
<ѻýҕl>Ocaliva for NASH Gets Thumbs Down From FDA Advisorsѻýҕl> Difficulty of risk mitigation for potential drug-induced liver injury weighed heavily on members May 19, 2023
<ѻýҕl>Rare Skin Blistering Condition Gets First Drug Approvedѻýҕl> FDA's decision marks first approval for a redosable gene therapy May 19, 2023
<ѻýҕl>FDA 'Leans In' to Accelerated Approval for Rare Disease Drugsѻýҕl> CBER director says "moment is tender for gene therapy," sees opportunity to "salvage" treatments May 19, 2023
<ѻýҕl>Should FDA Grant Accelerated Approval to Duchenne Muscular Dystrophy Gene Therapy?ѻýҕl> Waiting for the results of the SRP-9001 confirmatory trial may be a better move May 18, 2023
<ѻýҕl>First JAK Inhibitor Approved for Crohn's Diseaseѻýҕl> Upadacitinib lands indication for moderately to severely active disease in adults May 18, 2023
<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