<ѻýҕl>Drugmaker Pulls Third-Line PARP Inhibitor Approval in Ovarian Cancerѻýҕl> Decision on rucaparib follows negative OS signal and "discussions" with FDA Jun 17, 2022
<ѻýҕl>FDA OKs Risankizumab for Crohn's Diseaseѻýҕl> Approval marks the third indication for the IL-23 inhibitor in adults Jun 17, 2022
<ѻýҕl>FDA Allows mRNA COVID Vaccines in Kids 6 Months and Upѻýҕl> Vaccines expected to protect against most severe outcomes, says FDA Commissioner Jun 17, 2022
<ѻýҕl>FDA Approves First Systemic Treatment for Alopecia Areataѻýҕl> Four to 10 times as many patients met hair-regrowth endpoint with JAK inhibitor versus placebo Jun 13, 2022
<ѻýҕl>FDA Panel Backs Gene Tx for Degenerative Brain Disorder in Kidsѻýҕl> Advisers unanimously recommend approval for pediatric ALD patients without HLA-matched donors Jun 10, 2022
<ѻýҕl>It's High Noon for Dietary Supplementsѻýҕl> The user fee legislation in Congress proposes useful regulations, but doesn't go far enough Jun 10, 2022
<ѻýҕl>FDA Pulls Lymphoma Approvals for PI3K Inhibitor Umbralisibѻýҕl> Worse overall survival observed despite improvements in progression-free survival Jun 01, 2022
<ѻýҕl>Abbott Formula Plant Was 'Unacceptably Insanitary,' FDA Chief Tells Lawmakersѻýҕl> Abbott official says the company is "deeply, deeply sorry" about the formula shortage May 26, 2022
<ѻýҕl>FDA OKs First Novel Nonsteroidal Topical for Plaque Psoriasis in 25 Yearsѻýҕl> Complete, near-complete clearance in 35-40% of patients treated with tapinarof cream 1% May 24, 2022
<ѻýҕl>First Treatment Approved for Eosinophilic Esophagitisѻýҕl> FDA expands dupilumab's label to treat inflammatory condition May 20, 2022
<ѻýҕl>FDA Rejects Cheap Antidepressant to Treat Early COVIDѻýҕl> David Boulware, who submitted the EUA for fluvoxamine, argues the agency is "behind the times" May 17, 2022
<ѻýҕl>First GLP-1/GIP Receptor Agonist OK'd for Type 2 Diabetesѻýҕl> Injectable tirzepatide lands approval as an adjunct to diet and exercise May 13, 2022
<ѻýҕl>Restrictions on Mifepristone a Barrier to Miscarriage Care, Surveys Showѻýҕl> Over a third of respondents do not prescribe the drug for early pregnancy loss, despite efficacy May 10, 2022
<ѻýҕl>Early Alzheimer's Test Gets FDA Nodѻýҕl> First in vitro diagnostic to detect amyloid in early disease setting May 05, 2022
<ѻýҕl>Two New Regimens Win FDA Approval for H. Pylori Infectionѻýҕl> Dual and triple vonoprazan-based treatments offer physicians another set of options May 04, 2022
<ѻýҕl>How Far Should the Menthol Ban Go?ѻýҕl> It's time to ban menthol in cigarettes -- but not necessarily in all tobacco products May 02, 2022
<ѻýҕl>FDA OKs New Nonstimulant Option for Adult ADHDѻýҕl> New selective norepinephrine reuptake inhibitor is no longer just for kids May 02, 2022
<ѻýҕl>FDA Proposes Ban on Menthol Cigarettesѻýҕl> "Long-awaited action" should reduce youth smoking, health disparities Apr 28, 2022
<ѻýҕl>FDA Approves First Drug for Recurrent Yeast Infectionsѻýҕl> Vivjoa indicated for infertile or postmenopausal women Apr 28, 2022
<ѻýҕl>FDA Issues Warning on Prenatal Genetic Testsѻýҕl> Relying on results could lead to inappropriate medical decisions, agency warns Apr 19, 2022
<ѻýҕl>First Topical Therapy for Facial Angiofibroma Nabs FDA Approvalѻýҕl> New alternative to dermabrasion, laser treatment, surgery Apr 04, 2022
<ѻýҕl>ALS Drug Needs More Evidence, FDA Advisors Sayѻýҕl> But vote was close and panelists remain hopeful about AMX0035 Mar 31, 2022
<ѻýҕl>Another Oral Testosterone Undecanoate OK'd for Hypogonadismѻýҕl> FDA approval of Tlando follows in the footsteps of Jatenzo Mar 29, 2022
<ѻýҕl>Novel Fixed-Dose Immunotherapy Combo Wins FDA Approvalѻýҕl> Nivolumab plus relatlimab doubled progression-free survival in unresectable melanoma Mar 21, 2022
<ѻýҕl>Medicare Claws Back Money for Dubious Birth-Tissue Stem Cell Shotsѻýҕl> Government seeks to recoup more than 2 years of payments for unproven treatments Mar 16, 2022
<ѻýҕl>First Generic OK'd for Popular Asthma, COPD Inhalerѻýҕl> FDA approves Mylan's Symbicort copy, reflecting agency's commitment to "increase competition" Mar 15, 2022
<ѻýҕl>FDA Warns on Using Surgical Device for Aesthetic Skin Proceduresѻýҕl> Agency details potentially life-threatening adverse events with plasma-generating device Mar 14, 2022
<ѻýҕl>FDA OKs PARP Inhibitor as Adjuvant Therapy in Early Breast Cancerѻýҕl> Olaparib (Lynparza) approved for high-risk patients with germline BRCA mutations Mar 14, 2022
<ѻýҕl>Rare Vaccine Death; Vape Loophole Exploited; No Paxlovid for the Imprisonedѻýҕl> This past week in healthcare investigations Mar 09, 2022
<ѻýҕl>FDA Begins Releasing Pfizer COVID Vax Documentsѻýҕl> Court-ordered release runs risk of "cherry picking and taking things out of context" Mar 07, 2022
<ѻýҕl>Dr. Bronner's Offering Its Workers Psychedelic Therapy Coverageѻýҕl> Soap company to cover ketamine-assisted therapy for employees with new industry nonprofit Mar 01, 2022
<ѻýҕl>Thumbs Down for IV Tramadol, FDA Advisers Sayѻýҕl> Delayed onset of pain relief remains a concern Feb 16, 2022
<ѻýҕl>FDA OKs 180-Day Implantable Continuous Glucose Monitorѻýҕl> Senseonics' Eversense E3 System approved for adults with diabetes Feb 11, 2022
<ѻýҕl>FDA Warns of Strangulation Risk for Kids on Feeding Tubesѻýҕl> Two toddlers died after being found with enteral feeding systems' tubing around their necks Feb 09, 2022
<ѻýҕl>FDA Concerned About Safety of Lymphoma Drugѻýҕl> Hint of excess mortality in trial of umbralisib/ublituximab prompts public notice Feb 03, 2022
<ѻýҕl>FDA Approves First Generic of Restasis for Dry Eyeѻýҕl> A new option for those affected by keratoconjunctivitis sicca Feb 02, 2022
<ѻýҕl>Another COVID Vaccine Garners Full FDA Approvalѻýҕl> Moderna's Spikevax approved for adults ages 18 and up Jan 31, 2022
<ѻýҕl>Remdesivir Now Approved for COVID Outpatients, Tooѻýҕl> FDA expands indication of Veklury to bolster supply of treatment during Omicron surge Jan 22, 2022
<ѻýҕl>FDA OKs Two Oral JAK Inhibitors for Refractory Atopic Dermatitisѻýҕl> Once-daily abrocitinib and upadacitinib join topical ruxolitinib in expanding AD market Jan 18, 2022
<ѻýҕl>Growing Controversy Over 'Skinny' Labeling for Generic Drugsѻýҕl> What's at stake in legal battles over patent-avoiding approval pathway for generics Jan 17, 2022