Hold Off on Approving Anal Cancer Drug, Advisors Tell FDA ODAC recommends deferring approval of new PD-1 inhibitor until confirmatory trial results are in Jun 24, 2021
Start Thinking 'Cure'; One More Hug; Mortgages and Breast Cancer Survival News, features, and commentary about cancer-related issues Jun 16, 2021
The FDA Is Failing the American People The agency's recent decision to approve aducanumab offers more evidence of a broken system Jun 16, 2021
Docs, Scientists Call on FDA to Delay Approval of COVID Vaccines Data should be from completed phase III trials, not interim results, group says Jun 10, 2021
Op-Ed: Why Is Prescribing Information Still on Paper? Making electronic info the default is a small change with a big environmental impact Jun 04, 2021
Medtronic's LVAD Pulled From Market Due to Neurological, Mortality Risks Physicians must stop implanting the HeartWare system, says FDA Jun 03, 2021
Guns for Vaccinations; IU Health Joins the Mandate Club; NFL Ends 'Race-Norming' A daily roundup of news on COVID-19 and the rest of medicine Jun 03, 2021
Novel Aid to Help Diagnose Autism Gets FDA Nod Canvas Dx device may help early diagnoses and intervention in young children Jun 02, 2021
FDA OKs New Antipsychotic for Schizophrenia, Bipolar Disorder Approval of olanzapine-samidorphan carries opioid-related contraindications Jun 01, 2021
Are Vaccine Advisors More Conflicted Than We Thought? Rules for advisory committee members' disclosures vary widely May 28, 2021
Drug to Delay T1D Gets Tepid Endorsement by FDA Advisors Feelings mixed on safety and efficacy evidence for novel biologic May 28, 2021
FDA Restricts Ocaliva Use in Primary Biliary Cholangitis Liver failure, need for liver transplant reported in patients with advanced cirrhosis May 27, 2021
Bad Day Sunshine: Benzene Found in Many Sun Care Products Valisure also detected the carcinogen in hand sanitizers earlier this year May 26, 2021
FDA Draft Guidance on T2D Devices; New GLP-1 Drug Succeeds in Trial News and commentary from the endocrinology world May 23, 2021
House Dems Grill Emergent Execs Over Spoiled J&J Doses Mixed-up ingredients, wasted taxpayer dollars, potential insider training? May 20, 2021
Indian Variant a Global Risk; Good News on U.S. Cases; Baylor Expert Gets Threats A daily roundup of news on COVID-19 and the rest of medicine May 11, 2021
First COVID Treatment Ads Hit the Airwaves Regeneron hoping patients ask their doctors about monoclonal antibodies May 10, 2021
FDA Panel to Weigh Avacopan's Fate for ANCA Vasculitis Agency staff called out "interpretability" of phase III trial results ahead of Thursday's meeting May 05, 2021
Op-Ed: Is FDA's Cigarette Ban Just Smoke and Menthols? Actually implementing a ban on menthol cigarettes and cigars could take years May 03, 2021
Thumbs Up for New Birth Control Pill Across Multiple Subgroups No differences in efficacy or unscheduled bleeding based on age, BMI, or prior contraceptive use May 03, 2021
'It's a Straw-Man Argument': What We Heard This Week Quotable quotes from 51³ÉÈ˶¯Âþ's sources May 02, 2021
Farxiga Gets FDA Greenlight for CKD SGLT2 OK'd to prevent chronic kidney disease progression and cardiovascular risks Apr 30, 2021
FDA Panel Splits on Anti-PD-1 Monotherapy in HCC All thumbs up for pembrolizumab, pending further data, but no such luck for nivolumab Apr 30, 2021
PD-1 Inhibitor Approved for dMMR Endometrial Cancer Dostarlimab led to 42.3% response rate in recurrent/advanced disease Apr 22, 2021
ALS 'Compassionate Use' Again Hits National Media Expanded access campaigns will only become more frequent with growing rare disease pipelines Apr 20, 2021
Another Player in Advanced Bladder Cancer Accelerated FDA approval of sacituzumab govitecan after chemo, immunotherapy Apr 14, 2021
CDC Issues Health Advisory on J&J Shot; Pfizer Ramps Up; STDs at All-Time High A daily roundup of news on COVID-19 and the rest of medicine Apr 14, 2021
FDA Temporarily Lifts Restriction on Abortion Pill Allows clinicians to dispense mifepristone via telehealth during the pandemic Apr 13, 2021
Donor Heart Preserver Survives Review by FDA Advisors Panel had many bones to pick with the Transmedics OCS device Apr 07, 2021
Common Hospital PCR Test Affected by Viral Variant Cepheid Xpert joins three other tests for which B.1.1.7 can be problematic Apr 05, 2021
FDA: Arrhythmia Risk With Lamotrigine May Be Class Effect Agency updates warning for people with cardiac disease taking sodium channel blockers Apr 01, 2021
Novel Device OK'd to Treat MS Gait Deficits Tongue stimulator generates pulses to combat ataxia Mar 26, 2021
Harmony Pulmonary Valve Gets FDA Nod Transcatheter valve implantation approved for people without surgical RVOT conduits Mar 26, 2021
Overactive Bladder Drug Gains Pediatric Indication Mirabegron approved to treat kids with neurogenic detrusor overactivity Mar 26, 2021
FDA Panel Unhappy With Novel OA Pain Drug Latest setback for troubled osteoarthritis biologic Mar 25, 2021
Benzene Found in Multiple Hand Sanitizer Brands Known human carcinogen can be absorbed through the skin Mar 25, 2021
Op-Ed: Blood Cancer Patients Need More COVID Vax Answers Patients are left wondering, "will I be protected?" Mar 24, 2021
Banned Stimulants Again Found in Supplements Researchers question FDA's commitment to enforcement Mar 23, 2021
Op-Ed: Now Isn't the Time to Ignore the Opioid Crisis Swift federal action can remove barriers to life-saving treatment Mar 06, 2021
