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Nucala (mepolizumab) Approved by US FDA for Use in Adults with Chronic Obstructive Pulmonary Disease (COPD)

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment...

U.S. FDA Grants Approval for Jivi (Antihemophilic Factor (Recombinant), PEGylated-aucl) in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia A

(BUSINESS WIRE) May 19, 2025 --Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi, a recombinant DNA-derived, extended...

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...

Environmental SOS: Rare Birds Crunch From Bellies Full of Plastic

SATURDAY, May 24, 2025 — Birds on a remote Australian island are so full of plastic they crunch, British researchers report.They found plastic in the...

2015 to 2021 Saw Decrease in Incidence of Dementia

From 2015 to 2021, there was a decrease in the incidence of dementia, but an increase in prevalence, according to a study published online May 20 in The...

FDA Approves Nucala for Chronic Obstructive Pulmonary Disease

The U.S. Food and Drug Administration has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled...

Standardized Branding of Disposable Vaping Devices Reduces Young People's Interest

Standardizing the color and branding of disposable vaping devices reduces young people’s interest in trying them, according to a study published...

Swept-Source Anterior Segment OCT Can Help Distinguish Early Childhood Glaucoma

The noninvasive swept-source anterior-segment optical coherence tomography (SS-ASOCT) can diagnose early-onset childhood glaucoma, according to a study...

AI Three-Item Severity Score Can ID Eczema From Patient-Uploaded Images

An artificial intelligence (AI) Three-Item Severity (TIS) score can identify eczema-affected areas and severity scores from user-uploaded images, according...

Biden’s Prostate Cancer Likely Grew Undetected for Years, Experts Say

FRIDAY, May 23, 2025 — Former President Joe Biden's prostate cancer diagnosis has drawn attention to screening guidelines for older men.  When...

FDA Halts Sale of Off-Brand Ozempic and Other GLP-1 Drugs

FRIDAY, May 23, 2025 — A federal deadline ending sale of off-brand weight-loss and diabetes medications is now in effect, cutting off access to drugs...

FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

THURSDAY, May 22, 2025 — The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines. The...

Umary USA Issues Voluntary Nationwide Recall of Unavy Ácido Hialurónico Caplets and Umovy Ácido Hialurónico Caplets Due to the Presence of Undeclared Drug Ingredients

May 21 2025, Nogales, AZ, Umary USA is voluntarily recalling all lots of Unavy Ácido Hialurónico (30 caplets/850 mg) and Umovy...

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...

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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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