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FDA Grants Interchangeable Designation to Fresenius Kabi’s Biosimilar Otulfi (ustekinumab-aauz)

LAKE ZURICH, Ill., May 19, 2025 – Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S Food and...

FDA Approves Nuvaxovid (COVID-19 Vaccine, Adjuvanted) to Prevent COVID-19

Novavax, Inc. (Nasdaq: NVAX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for...

Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States

(BUSINESS WIRE)--May 15, 2025-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved...

FDA Grants Accelerated Approval to Emrelis (telisotuzumab vedotin-tllv) for Non-Small Cell Lung Cancer With High c-Met Protein Overexpression

 AbbVie (NYSE: ABBV) today announced that Emrelis (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug...

FDA Approves Zynyz as First-Line Treatment for Advanced Anal Cancer

The U.S. Food and Drug Administration has approved the humanized monoclonal antibody, Zynyz, (retifanlimab-dlwr) as the first first-line treatment for...

No Increase Seen in Neurodevelopmental Disorders With Prenatal Triptan Use

Children prenatally exposed to different triptan intensities and duration, alone or in combination with other preventive medications for migraine, do not...

Tumor-Related Epilepsy Not Strong Prognostic Factor in Diffuse Glioma

For patients with diffuse gliomas, tumor-related epilepsy (TRE) is not a strong prognostic factor, according to a study published in the May issue of Brain...

Lipoprotein(a) Levels Tied to Increased Risk of Recurrent Atherosclerotic CVD Events

Higher lipoprotein(a) levels are associated with continuously increasing risk of recurrent atherosclerotic cardiovascular disease (ASCVD) events, regardless...

PREVENT Risk Score Accurately IDs People With Coronary Artery Calcium

The 2023 Predicting Risk of Cardiovascular Disease Events (PREVENT) risk score accurately identifies individuals with coronary artery calcium (CAC), according...

Florida-Grown Cucumbers Behind Salmonella Outbreak, CDC Warns

WEDNESDAY, May 21, 2025 — Health officials are investigating a salmonella outbreak tied to cucumbers grown in Florida.  At least 26 people...

Nebraska First State to Ban Soda, Energy Drinks From SNAP Program

WEDNESDAY, May 21, 2025 — Nebraska is the first state to get federal approval to ban the purchase of soda and energy drinks under the Supplemental...

FDA Limits COVID-19 Boosters to Seniors, Other High-Risk Groups

WEDNESDAY May 21, 2025 — The U.S. Food and Drug Administration (FDA) has decided that only seniors and people at high risk should get the latest...

Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-Daily Oral Pill for Obstructive Sleep Apnea

CAMBRIDGE, Mass., May 19, 2025 – Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates...

Global Phase III Trials Demonstrate That Nerandomilast Slowed Lung Function Decline in IPF and PPF, with Similar Discontinuation Rates to Placebo

Ingelheim, Germany, May 19, 2025 - Boehringer Ingelheim announced today detailed findings from the Phase III FIBRONEER™-IPF and FIBRONEER™-ILD...

Toxic Metals Found in All Rice Samples in New Study

FRIDAY, May 16, 2025 — A new report says rice sold in U.S. stores contains toxic heavy metals, including arsenic, cadmium, lead and mercury. The...

FDA Drug Safety Communication: FDA Requires Warning About the Risk of Pruritus After Stopping Long-Term Use of Cetirizine or Levocetirizine

FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal,...

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Latest FDA New Drug Approvals

  • Nuvaxovid Nuvaxovid (COVID-19 Vaccine, Adjuvanted) is a protein-based, non-MRNA vaccine for active immunization to prevent coronavirus disease 2019...
  • Emrelis Emrelis (telisotuzumab vedotin) is a first-in-class, c-Met protein directed antibody-drug conjugate for the treatment of non-squamous...
  • Avmapki Fakzynja Co-Pack Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) is a kinase inhibitor combination for the treatment of KRAS-mutated...

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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...

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