Families Push Research Forward in Rare Diseases The field has a unique funding model. While fruitful, some question if it needs to change. Dec 26, 2022
FDA Approves First Gene Therapy for Non-Muscle-Invasive Bladder Cancer Half of patients achieved complete responses with adenoviral vector-based product Dec 16, 2022
'Constant Turmoil' at FDA Makes Our Food Less Safe Reflections on a new report about the agency's Human Foods Program Dec 16, 2022
Why Does Makena Remain on the Market? Misguided equity claims do not resolve issues with the accelerated approval program Dec 11, 2022
New IDH1 Inhibitor Wins FDA Approval for Acute Myeloid Leukemia Olutasidenib led to a 35% response rate in a study of adults with previously treated AML Dec 02, 2022
FDA Greenlights First Fecal Microbiota Product Rebyota approved for preventing recurrence of C. difficile infection Dec 01, 2022
Watch for Severe Hypocalcemia in Dialysis Patients on Prolia, FDA Warns Agency said potential risk may require more frequent blood calcium monitoring Nov 22, 2022
FDA Approves First Drug to Delay Onset of Type 1 Diabetes Teplizumab will not be subject to a risk evaluation and mitigation strategy program, after all Nov 18, 2022
FDA Panel Endorses Kidney Disease Drug for Serum Phosphorus Control Advisors see need for alternatives, citing suboptimal efficacy and tolerance of approved options Nov 17, 2022
After Rejection, Tenapanor for Kidney Disease Faces FDA's Outside Experts Drug's effect on serum phosphorus "small and of unclear clinical significance," say FDA reviewers Nov 15, 2022
FDA OKs First Antibody-Drug Conjugate for Platinum-Resistant Ovarian Cancer Mirvetuximab soravtansine produced responses in almost a third of patients in pivotal trial Nov 15, 2022
Another Adalimumab Biosimilar Seems Set for Interchangeability Trial data pave way for FDA approval Nov 14, 2022
FDA Authorizes IL-1 Drug for Hospitalized COVID Patients Anakinra indicated for patients with pneumonia who are at risk of severe respiratory failure Nov 09, 2022
COVID Spread Through Floors, Walls; Infant Pillow Warning; Paul Pelosi Discharged Health news and commentary from around the Web gathered by ΒιΆΉ΄«Γ½ staff Nov 04, 2022
Pulse Oximeters Need to Work Better for Dark-Skinned Patients, FDA Panel Says Warnings to patients and providers, improved accuracy needed, advisors say Nov 02, 2022
The Updated COVID Boosters Could Have Been Better From design to implementation, our bivalent shots missed the mark Oct 26, 2022
FDA Broadens Options for Relapsed/Refractory Multiple Myeloma With Teclistamab Bispecific antibody achieved durable responses in a majority of heavily pretreated patients Oct 25, 2022
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
