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FDA Approves Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care...

FDA Approves Hympavzi (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors

(BUSINESS WIRE) October 11, 2024 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq)...

IDSA: MVA-BN Vaccine Against Mpox Tolerated, Effective for Teens

The Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine, licensed in the United States to prevent smallpox and mpox, is well tolerated and seems...

IDSA: EHR Order Set Reduces Antibiotic Duration in Children With AOM

Implementation of an electronic health record (EHR) order set increases compliance with the recommended duration of prescribed antibiotics for children...

Racial, Gender, Socioeconomic Disparities Seen in Teen Alcohol, Drug Screening

Rates of biochemical alcohol and drug screening are disproportionately higher among adolescent trauma patients who are from racial and ethnic minorities,...

In Utero Exposure to COVID-19 Not Tied to Later Neurodevelopmental Issues

Exposure to maternal COVID-19 is not associated with abnormal neurodevelopmental screening results through 24 months postpartum, according to a study published...

Vaping Rates Hit Record Lows for U.S. High School Students

Is vaping finally losing its coolness for American teens? The latest tally of federal data finds that 550,000 school kids, mostly high schoolers, quit...

New Drug Regimen Extends Survival for Cervical Cancer Patients

In some good news for women battling locally advanced cervical cancer, new research shows that adding six weeks of chemotherapy to standard treatment cuts...

Oct. 7 Tragedy Spurs Israeli Researcher to Study Grief Over Sibling Loss

A young Israeli researcher who lost a sibling in the Oct. 7, 2023 Hamas attack on Israeli civilians said the tragedy has spurred her to study the unique...

The Right Time is Now to Get Your Flu Vaccine

Folks who want solid protection during the cold and flu season should get the influenza vaccine now, the U.S. Food and Drug Administration says. The ideal...

Update on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

 Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S....

NIH and FDA Leaders Call for Innovation in Development of Smoking Cessation Treatments

In a new commentary in the Annals of Internal Medicine, leaders at the National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA)...

Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome

NEEDHAM, Mass., Oct. 11, 2024 /PRNewswire/ — Stealth BioTherapeutics Inc. (the “Company” or “Stealth”), a clinical-stage...

Almost 10 Million Pounds of Meat Recalled Due to Listeria Danger

Oklahoma meat processor BrucePac is recalling close to 10 million pounds of ready-to-eat meat and poultry that may have been contaminated with the...

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Recently added consumer and prescribing information: Imuldosa, Hympavzi, Flyrcado, Otulfi, Tecentriq Hybreza, Pavblu, Livdelzi, Yorvipath, Crexont, Lymphir

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Latest FDA New Drug Approvals

  • Imuldosa Imuldosa (ustekinumab-srlf) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis...
  • Hympavzi Hympavzi (marstacimab-hncq) is a tissue factor pathway inhibitor (TFPI) antagonist used for the treatment of adults and adolescents with...
  • Itovebi Itovebi (inavolisib) is a phosphatidylinositol 3-kinase (PI3K) alpha inhibitor used for the combination treatment of PIK3CA-mutated...

More FDA approvals

Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil tentatively approved for the treatment of pulmonary arterial...

More drugs in development