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A photo of a box of the Pfizer-BioNTech bivalent COVID-19 vaccine

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

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

FDA APPROVED Lecanemab-irmb (Leqembi) over a computer rendering of amyloid plaques forming between neurons

Alzheimer's Drug Lecanemab Wins FDA Approval

Anti-amyloid showed modest benefit in phase III trial, but was linked to adverse events

A photo of the packaging and blisterpack of a Mifeprex pill

Abortion Pill Can Be Dispensed in Retail Pharmacies, FDA Says

Decision allows patients to pick up mifepristone at brick-and-mortar locations

A computer rendering of a macrophage and cancer cells.

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

FDA APPROVED ublituximab (Briumvi) over a computer rendering of a motor neuron with a degrading myelin sheath

Anti-CD20 Agent Gains Approval for Multiple Sclerosis

FDA greenlights ublituximab for relapsing MS

FDA APPROVED semaglutide 2.4 mg (Wegovy) over a photo of a teen girl laying on grass taking a selfie.

Wegovy OK'd for Teens With Obesity

New indication for popular weight-loss injectable

A photo of canisters of Enfamil on mostly empty store shelves.

No, the Baby Formula Shortage Still Isn't Over

Experts say regulatory changes treat symptoms but not all causes of the formula crisis

A photo of Charles Venditti, MD, PhD, meeting with a young female patient.

Families Push Research Forward in Rare Diseases

The field has a unique funding model. While fruitful, some question if it needs to change.

FDA APPROVED nadofaragene firadenovec-vncg (Adstiladrin) over a computer rendering of bladder cancer.

FDA Approves First Gene Therapy for Non-Muscle-Invasive Bladder Cancer

Half of patients achieved complete responses with adenoviral vector-based product

A photo of the headquarters of US Food and Drug Administration in Silver Spring Maryland

'Constant Turmoil' at FDA Makes Our Food Less Safe

Reflections on a new report about the agency's Human Foods Program

A photo of a Makena auto-injector pen laying on a shelf in a medicine cabinet.

Why Does Makena Remain on the Market?

Misguided equity claims do not resolve issues with the accelerated approval program

FDA APPROVED olutasidenib (Rezlidhia) over a computer rendering of acute myeloid leukemia cells.

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

FDA APPROVED Fecal microbiota, live (Rebyota) over a computer rendering of Clostridioides difficile bacteria.

FDA Greenlights First Fecal Microbiota Product

Rebyota approved for preventing recurrence of C. difficile infection

A kidney patient receives treatment at a hospital.

Watch for Severe Hypocalcemia in Dialysis Patients on Prolia, FDA Warns

Agency said potential risk may require more frequent blood calcium monitoring

FDA APPROVED teplizumab (Tzield) over a photo of a woman checking her blood glucose.

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

FDA ADCOMM tenapanor (Ibsrela) over a photo of a bottle of Ibsrela tablets over a computer rendering of kidney disease.

FDA Panel Endorses Kidney Disease Drug for Serum Phosphorus Control

Advisors see need for alternatives, citing suboptimal efficacy and tolerance of approved options

FDA ADCOMM tenapanor hydrochloride tablets over a bottle of IBSRELA tablets over a rendering of chronic kidney disease

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

FDA APPROVED mirvetuximab soravtansine (Elahere) over a computer rendering of ovarian cancer.

FDA OKs First Antibody-Drug Conjugate for Platinum-Resistant Ovarian Cancer

Mirvetuximab soravtansine produced responses in almost a third of patients in pivotal trial

ACR over a photo of Pennsylvania Convention Center in Philadelphia, Pennsylvania

Another Adalimumab Biosimilar Seems Set for Interchangeability

Trial data pave way for FDA approval

FDA EUA anakinra (Kineret) over a photo of the prefilled syringe and packaging of Kineret.

FDA Authorizes IL-1 Drug for Hospitalized COVID Patients

Anakinra indicated for patients with pneumonia who are at risk of severe respiratory failure

Morning Break over illustration of a syringe, Covid virus, and DNA helix over a photo of green vegetation.

COVID Spread Through Floors, Walls; Infant Pillow Warning; Paul Pelosi Discharged

Health news and commentary from around the Web gathered by 番茄社区 staff

Photo of a man monitoring oxygen saturation with a pulse oximeter.

Pulse Oximeters Need to Work Better for Dark-Skinned Patients, FDA Panel Says

Warnings to patients and providers, improved accuracy needed, advisors say

A photo of a vial of the Moderna bivalent COVID booster.

The Updated COVID Boosters Could Have Been Better

From design to implementation, our bivalent shots missed the mark

FDA APPROVED teclistamab-cqyv (TECVAYLI) over a computer rendering of multiple myeloma cells.

FDA Broadens Options for Relapsed/Refractory Multiple Myeloma With Teclistamab

Bispecific antibody achieved durable responses in a majority of heavily pretreated patients

Makena Is Just the Latest in Accelerated Approval Mayhem

Congress must take action to reform the process

FDA APPROVED tremelimumab (Imjudo) over a computer rendering of a transparent body with a diseased liver highlighted.

FDA Approves New CTLA-4 Inhibitor for Cancer Treatment

Tremelimumab (Imjudo), in combination with durvalumab, lands approval in advanced liver cancer

A photo of a swab laying on a petri dish which is laying on a DNA sequencing gel.

Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say

False positives, false negatives remain a concern

FDA ADCOMM hydroxyprogesterone caproate (Makena) over a photo of a Makena injection pen.

Revoke Approval of Preterm Birth Drug, FDA Advisors Say

Makena is ineffective, argued FDA panel

FDA ADCOMM hydroxyprogesterone caproate (Makena) over a photo of a Makena auto injector.

FDA Moves to Pull Controversial Preterm Birth Drug From the Market

Briefing data show Makena was ineffective in reducing preterm birth, improving neonatal outcomes

A photo of a box of Relyvrio.

Why I Voted 'No' on the New ALS Drug

Here are the shortcomings I saw in the phase II Relyvrio study

FDA APPROVED Subcutaneously injected furosemide (Furoscix) over a photo of a woman wearing the FUROSCIX On-Body Infusor

FDA Approves At-Home Furosemide for Heart Failure

Strong diuretic to become available outside the hospital setting

tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix) over a photo of a baby cough

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

HFSA over a photo of the Gaylord National Resort and Convention Center in Prince George鈥檚 County, Maryland

The Search Is On for Another Xeno Heart Transplant Recipient

Transplant surgeons discuss testing the concept in more humans

IGCS over a photo of the Jacob K. Javits Convention Center in New York City

FDA's Power Morcellator Warning Tied to Drop in Distant Leiomyosarcomas

Local and regional illness remained unchanged

A photo of a woman with prurigo nodularis on the back of her hands.

Dupilumab Gets First FDA-Approved Indication for Prurigo Nodularis

Significant improvement in itch and nodules at 24 weeks seen in two randomized trials

FDA APPROVED elivaldogene autotemcel (Skysona) over a photo of a woman holding her boy who suffers from adrenoleukodystrophy

Gene Therapy for Degenerative Brain Disorder Wins FDA Nod

$3 million price tag for one-time treatment

FDA APPROVED terlipressin (Terlivaz) over a computer rendering of a kidney in a transparent body.

FDA Finally OKs First Drug for Hepatorenal Syndrome

Pivotal trial data showed terlipressin nearly doubled reversal of the condition

Plaque psoriasis

First TYK2 Inhibitor for Psoriasis Wins FDA Approval

Deucravacitinib significantly outperformed apremilast in two randomized trials

FDA APPROVED Monoclonal antibody spesolimab (Spevigo) over a photo of pustular psoriasis.

First Approved Treatment for Generalized Pustular Psoriasis

Spesolimab led to complete clearance of pustules within a week in more than half of patients

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