What Happened to the Monoclonal Antibodies for COVID-19? Losing focus on monoclonals means neglecting those who need them most: the immunocompromised Feb 13, 2023 video
FDA Warns on Use of Hospira Drug in Kids Due to 'Unsafe' Aluminum Levels Agency cites risk for aluminum toxicity in infants Feb 10, 2023
FDA Has Concerns on 'Unprecedented' Plan for Dostarlimab in Rectal Cancer Panel will discuss if single-arm trials and proposed endpoints are adequate to support approval Feb 08, 2023
Ketamine Clinics Are Jumping Ahead of the Evidence New mental health treatments must be approached with caution Feb 05, 2023
How Patent Thickets Keep Cheaper Drugs Off the Market "We're transferring a huge amount of wealth from the public to drug companies," says S. Sean Tu Feb 03, 2023 video
What Doctors Should Know About Xylazine in Fentanyl Naloxone still works but additional support may be needed; wound care a challenge Feb 01, 2023
FDA Greenlights First Drug for ESR1-Mutated Breast Cancer Elacestrant almost doubled PFS versus standard endocrine therapy in advanced ER+/HER2- disease Jan 30, 2023
Doc Delivered Deadly Epidural; Hotze's Conspiracy Theory; Docs Slam Wegovy Story This past week in healthcare investigations Jan 25, 2023
FDA, NIH Must Penalize Researchers Who Don't Report Trial Results, House Member Says Many with NIH grants don't follow reporting rules, get funded again anyway, says Rep. Pallone Jan 20, 2023
CDC, FDA Flag Early Signal of Stroke Risk With Bivalent COVID Vaccine One surveillance system detects potential link in seniors, yet multiple others show none Jan 13, 2023
Legal Loophole Lets Faulty Devices Maintain Their Legacy Harlan Krumholz on how devices subject to Class I recalls are used as predicates for new devices Jan 11, 2023 video
Alzheimer's Drug Lecanemab Wins FDA Approval Anti-amyloid showed modest benefit in phase III trial, but was linked to adverse events Jan 06, 2023
Abortion Pill Can Be Dispensed in Retail Pharmacies, FDA Says Decision allows patients to pick up mifepristone at brick-and-mortar locations Jan 04, 2023
Crystal Ball Cloudy for PI3K Inhibitors' Future in Hematology After a year of negative news, some caution about throwing out the baby with the bath water Jan 02, 2023
Anti-CD20 Agent Gains Approval for Multiple Sclerosis FDA greenlights ublituximab for relapsing MS Dec 29, 2022
No, the Baby Formula Shortage Still Isn't Over Experts say regulatory changes treat symptoms but not all causes of the formula crisis Dec 28, 2022
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 ·¬ΗΡΙηΗψ 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
