Makena Is Just the Latest in Accelerated Approval Mayhem Congress must take action to reform the process Oct 24, 2022
FDA Approves New CTLA-4 Inhibitor for Cancer Treatment Tremelimumab (Imjudo), in combination with durvalumab, lands approval in advanced liver cancer Oct 24, 2022
Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say False positives, false negatives remain a concern Oct 21, 2022
Revoke Approval of Preterm Birth Drug, FDA Advisors Say Makena is ineffective, argued FDA panel Oct 19, 2022
FDA Moves to Pull Controversial Preterm Birth Drug From the Market Briefing data show Makena was ineffective in reducing preterm birth, improving neonatal outcomes Oct 14, 2022
Why I Voted 'No' on the New ALS Drug Here are the shortcomings I saw in the phase II Relyvrio study Oct 13, 2022
FDA Approves At-Home Furosemide for Heart Failure Strong diuretic to become available outside the hospital setting Oct 10, 2022
FDA OKs Tdap Vaccine for Whooping Cough Protection Before Birth Boostrix vaccine is to be delivered to the unborn child in the third trimester of pregnancy Oct 07, 2022
The Search Is On for Another Xeno Heart Transplant Recipient Transplant surgeons discuss testing the concept in more humans Oct 04, 2022
FDA's Power Morcellator Warning Tied to Drop in Distant Leiomyosarcomas Local and regional illness remained unchanged Oct 04, 2022
Dupilumab Gets First FDA-Approved Indication for Prurigo Nodularis Significant improvement in itch and nodules at 24 weeks seen in two randomized trials Sep 29, 2022
Gene Therapy for Degenerative Brain Disorder Wins FDA Nod $3 million price tag for one-time treatment Sep 19, 2022
FDA Finally OKs First Drug for Hepatorenal Syndrome Pivotal trial data showed terlipressin nearly doubled reversal of the condition Sep 15, 2022
First TYK2 Inhibitor for Psoriasis Wins FDA Approval Deucravacitinib significantly outperformed apremilast in two randomized trials Sep 11, 2022
First Approved Treatment for Generalized Pustular Psoriasis Spesolimab led to complete clearance of pustules within a week in more than half of patients Sep 07, 2022
FDA Data Link Diabetes Drug Class to Gallbladder Disease FAERS analysis turns up dozens of cases of acute cholecystitis tied to GLP-1 receptor agonists Aug 30, 2022
FDA Warns on Potential for Monkeypox Spread via Fecal Transplant Agency urges additional protections around donor screening Aug 24, 2022
Biden Administration Authorizes Intradermal Use of Monkeypox Vaccine Move is expected to increase available doses by five-fold Aug 10, 2022
False Claims About COVID Vax Animal Testing Resurface Misinformation promoted by Texas lawmaker in 2021 pops up again on Twitter Aug 09, 2022
I Got Monkeypox Drugs -- Not Everyone Is So Lucky Increasing access to testing, vaccination, and treatment is critical to slowing the spread Aug 03, 2022
FDA OKs First Interchangeable Ranibizumab Biosimilar When available, Cimerli qualifies for pharmacy-level substitution for reference drug Aug 03, 2022
Are Skin Lesion Analyzers Ready for Prime Time? FDA panel not fully on board to reclassify computer-aided melanoma detection devices Jul 30, 2022
Dear Insurers: It's Time to Cover Weight Loss Drugs Universal coverage can increase medication access and improve population health Jul 27, 2022
Banned Supplements Still Available to Buy Online After FDA Warnings FDA should follow up on warning letters, researchers urge Jul 26, 2022
Topical JAK Inhibitor OK'd for Repigmentation of Vitiligo Significantly more patients achieved 75%, 90% improvement Jul 19, 2022
FDA Getting Tougher on Birth Tissue Companies Agency calls out manufacturer on orthopedic indications Jul 06, 2022
FDA Warns of Increased Mortality Risk With Duvelisib Drug approved for adults with CLL/SLL Jul 01, 2022
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
