FDA Expands Use of Weight-Loss Drug to Adolescents Qsymia now approved for teens with obesity, along with diet and exercise Jun 28, 2022
Should Young and Healthy Patients Take Paxlovid? The antiviral has not been shown to be valuable in this population Jun 26, 2022
Drugmaker Pulls Third-Line PARP Inhibitor Approval in Ovarian Cancer Decision on rucaparib follows negative OS signal and "discussions" with FDA Jun 17, 2022
FDA OKs Risankizumab for Crohn's Disease Approval marks the third indication for the IL-23 inhibitor in adults Jun 17, 2022
FDA Allows mRNA COVID Vaccines in Kids 6 Months and Up Vaccines expected to protect against most severe outcomes, says FDA Commissioner Jun 17, 2022
FDA Approves First Systemic Treatment for Alopecia Areata Four to 10 times as many patients met hair-regrowth endpoint with JAK inhibitor versus placebo Jun 13, 2022
FDA Panel Backs Gene Tx for Degenerative Brain Disorder in Kids Advisers unanimously recommend approval for pediatric ALD patients without HLA-matched donors Jun 10, 2022
It's High Noon for Dietary Supplements The user fee legislation in Congress proposes useful regulations, but doesn't go far enough Jun 10, 2022
FDA Pulls Lymphoma Approvals for PI3K Inhibitor Umbralisib Worse overall survival observed despite improvements in progression-free survival Jun 01, 2022
Abbott Formula Plant Was 'Unacceptably Insanitary,' FDA Chief Tells Lawmakers Abbott official says the company is "deeply, deeply sorry" about the formula shortage May 26, 2022
FDA OKs First Novel Nonsteroidal Topical for Plaque Psoriasis in 25 Years Complete, near-complete clearance in 35-40% of patients treated with tapinarof cream 1% May 24, 2022
First Treatment Approved for Eosinophilic Esophagitis FDA expands dupilumab's label to treat inflammatory condition May 20, 2022
FDA Rejects Cheap Antidepressant to Treat Early COVID David Boulware, who submitted the EUA for fluvoxamine, argues the agency is "behind the times" May 17, 2022
First GLP-1/GIP Receptor Agonist OK'd for Type 2 Diabetes Injectable tirzepatide lands approval as an adjunct to diet and exercise May 13, 2022
Restrictions on Mifepristone a Barrier to Miscarriage Care, Surveys Show Over a third of respondents do not prescribe the drug for early pregnancy loss, despite efficacy May 10, 2022
Early Alzheimer's Test Gets FDA Nod First in vitro diagnostic to detect amyloid in early disease setting May 05, 2022
Two New Regimens Win FDA Approval for H. Pylori Infection Dual and triple vonoprazan-based treatments offer physicians another set of options May 04, 2022
How Far Should the Menthol Ban Go? It's time to ban menthol in cigarettes -- but not necessarily in all tobacco products May 02, 2022
FDA OKs New Nonstimulant Option for Adult ADHD New selective norepinephrine reuptake inhibitor is no longer just for kids May 02, 2022
FDA Proposes Ban on Menthol Cigarettes "Long-awaited action" should reduce youth smoking, health disparities Apr 28, 2022
FDA Approves First Drug for Recurrent Yeast Infections Vivjoa indicated for infertile or postmenopausal women Apr 28, 2022
FDA Issues Warning on Prenatal Genetic Tests Relying on results could lead to inappropriate medical decisions, agency warns Apr 19, 2022
First Topical Therapy for Facial Angiofibroma Nabs FDA Approval New alternative to dermabrasion, laser treatment, surgery Apr 04, 2022
ALS Drug Needs More Evidence, FDA Advisors Say But vote was close and panelists remain hopeful about AMX0035 Mar 31, 2022
Another Oral Testosterone Undecanoate OK'd for Hypogonadism FDA approval of Tlando follows in the footsteps of Jatenzo Mar 29, 2022
Novel Fixed-Dose Immunotherapy Combo Wins FDA Approval Nivolumab plus relatlimab doubled progression-free survival in unresectable melanoma Mar 21, 2022
Medicare Claws Back Money for Dubious Birth-Tissue Stem Cell Shots Government seeks to recoup more than 2 years of payments for unproven treatments Mar 16, 2022
Meet the Primary Care Doc Who Wants the World to Go Back to Normal Lucy McBride, MD, has become a loud, controversial voice in the debate on COVID precautions Mar 15, 2022
First Generic OK'd for Popular Asthma, COPD Inhaler FDA approves Mylan's Symbicort copy, reflecting agency's commitment to "increase competition" Mar 15, 2022
FDA Warns on Using Surgical Device for Aesthetic Skin Procedures Agency details potentially life-threatening adverse events with plasma-generating device Mar 14, 2022
FDA OKs PARP Inhibitor as Adjuvant Therapy in Early Breast Cancer Olaparib (Lynparza) approved for high-risk patients with germline BRCA mutations Mar 14, 2022
FDA Begins Releasing Pfizer COVID Vax Documents Court-ordered release runs risk of "cherry picking and taking things out of context" Mar 07, 2022
Dr. Bronner's Offering Its Workers Psychedelic Therapy Coverage Soap company to cover ketamine-assisted therapy for employees with new industry nonprofit Mar 01, 2022
Thumbs Down for IV Tramadol, FDA Advisers Say Delayed onset of pain relief remains a concern Feb 16, 2022
FDA OKs 180-Day Implantable Continuous Glucose Monitor Senseonics' Eversense E3 System approved for adults with diabetes Feb 11, 2022
FDA Warns of Strangulation Risk for Kids on Feeding Tubes Two toddlers died after being found with enteral feeding systems' tubing around their necks Feb 09, 2022
FDA Concerned About Safety of Lymphoma Drug Hint of excess mortality in trial of umbralisib/ublituximab prompts public notice Feb 03, 2022
FDA Approves First Generic of Restasis for Dry Eye A new option for those affected by keratoconjunctivitis sicca Feb 02, 2022
Another COVID Vaccine Garners Full FDA Approval Moderna's Spikevax approved for adults ages 18 and up Jan 31, 2022
Are We Equipped to Care for People With Intellectual, Developmental Disabilities? Low accreditation standards are contributing to health disparities Jan 20, 2022
