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FDA General

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

<乌鸦传媒>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.

<乌鸦传媒>FDA Greenlights First Fecal Microbiota Product

Rebyota approved for preventing recurrence of C. difficile infection

A kidney patient receives treatment at a hospital.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>COVID Spread Through Floors, Walls; Infant Pillow Warning; Paul Pelosi Discharged

Health news and commentary from around the Web gathered by 乌鸦传媒 staff

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>FDA Broadens Options for Relapsed/Refractory Multiple Myeloma With Teclistamab

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

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>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

<乌鸦传媒>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.

<乌鸦传媒>FDA Finally OKs First Drug for Hepatorenal Syndrome

Pivotal trial data showed terlipressin nearly doubled reversal of the condition

Plaque psoriasis

<乌鸦传媒>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.

<乌鸦传媒>First Approved Treatment for Generalized Pustular Psoriasis

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

A computer rendering close up of gallstones.

<乌鸦传媒>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

A computer rendering of a capsule filled with colorful microbiota

<乌鸦传媒>FDA Warns on Potential for Monkeypox Spread via Fecal Transplant

Agency urges additional protections around donor screening

A screenshot of a Press Briefing by White House Monkeypox Response Team and Public Health Officials

<乌鸦传媒>Biden Administration Authorizes Intradermal Use of Monkeypox Vaccine

Move is expected to increase available doses by five-fold

A photo of white rats in cages in a laboratory.

<乌鸦传媒>False Claims About COVID Vax Animal Testing Resurface

Misinformation promoted by Texas lawmaker in 2021 pops up again on Twitter

A photo of Kyle Planck

<乌鸦传媒>I Got Monkeypox Drugs -- Not Everyone Is So Lucky

Increasing access to testing, vaccination, and treatment is critical to slowing the spread

FDA APPROVED ranibizumab biosimilar ranibizumab-eqrn (Cimerli) over a photo of macular degeneration.

<乌鸦传媒>FDA OKs First Interchangeable Ranibizumab Biosimilar

When available, Cimerli qualifies for pharmacy-level substitution for reference drug

FDAADCOMM Computer-aided melanoma detection devices MelaFind and Nevisense over photos of the two devices.

<乌鸦传媒>Are Skin Lesion Analyzers Ready for Prime Time?

FDA panel not fully on board to reclassify computer-aided melanoma detection devices

A photo of a young female nurse adjusting the weights on a beam scale as she weighs her mature female patient.

<乌鸦传媒>Dear Insurers: It's Time to Cover Weight Loss Drugs

Universal coverage can increase medication access and improve population health

A photo of the dietary supplements aisle in a Walgreens pharmacy.

<乌鸦传媒>Banned Supplements Still Available to Buy Online After FDA Warnings

FDA should follow up on warning letters, researchers urge

FDA APPROVED Topical ruxolitinib (Opzelura) over a photo of a woman with vitiligo on her face and neck.

<乌鸦传媒>Topical JAK Inhibitor OK'd for Repigmentation of Vitiligo

Significantly more patients achieved 75%, 90% improvement

A photo of a technician lowering a washed section of umbilical cord into a storage container.

<乌鸦传媒>FDA Getting Tougher on Birth Tissue Companies

Agency calls out manufacturer on orthopedic indications

FDA WARNING duvelisib (Copiktra) over a photo of the packaging and blisterpack of Copiktra

<乌鸦传媒>FDA Warns of Increased Mortality Risk With Duvelisib

Drug approved for adults with CLL/SLL

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