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FDA Approves Kirsty (insulin aspart-xjhz), an Interchangeable Biosimilar to NovoLog

BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India: July 15, 2025 -- Biocon Biologics Ltd (BBL), a fully integrated global...

U.S. FDA Approves Kerendia (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority Review

WHIPPANY, N.J., July 14, 2025 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved Kerendia (finerenone) to treat patients...

Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease

CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration...

Update on CARES Phase III Clinical Programme of Anselamimab in Light Chain Amyloidosis

High-level results from the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme showed that anselamimab, a light chain...

WHO, UNICEF Say More Than 14 Million Infants Worldwide Remain Unvaccinated

Data released this week by the World Health Organization and UNICEF indicate modest gains in childhood vaccination rates, but globally, more than 14 million...

Most U.S. Adults Lack Awareness of Processed Foods

Most U.S. adults cannot identify processed foods correctly, according to a study published online July 8 in JAMA Network Open. Neal D. Barnard, M.D.,...

Illness Expectations Tied to Asthma Outcomes

Illness expectations may be meaningfully associated with asthma symptoms and respiratory function, according to a study published online in the June issue...

U.S. Children Became Increasingly Unhealthy in Recent Decades

The health of U.S. children worsened across a wide range of health indicator domains during the past 17 years, according to a study published online July...

Anticholinergics Tied to Physical Performance Decline in Older Adults

Anticholinergics are associated with physical performance decline in older adults, according to a study published online July 10 in JAMA Network Open. Shelly...

Thousands Laid off From NIH, FDA and CDC After Supreme Court Decision

WEDNESDAY, July 16, 2025 — Thousands of health workers lost their jobs this week after a U.S. Supreme Court ruling cleared the way for the Trump...

Court Allows West Virginia to Restrict Abortion Pill Mifepristone

WEDNESDAY, July 16, 2025 — A federal appeals court has ruled that West Virginia can limit access to mifepristone, a medication used to end early...

Popular YoCrunch Yogurt Recalled Over Plastic Pieces in Packaging

WEDNESDAY, July 16, 2025 — YoCrunch yogurt products are being pulled from store shelves nationwide due to a safety concern, its manufacturer announced...

FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine

The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine,...

Adagene Announces Regulatory Update on Clinical Development Plan for Muzastotug in Microsatellite Stable Colorectal Cancer Following Productive Type B (End of Phase 1) Meeting with FDA

SAN DIEGO and SUZHOU, China, July 15, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq:...

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

UPDATE July 14, 2025 – Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin...

Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

(BUSINESS WIRE)--Jul. 14, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development...

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company...

Popular Chronic Pain Med, Gabapentin, Linked To Dementia Risk

FRIDAY, July 11, 2025 — A drug used to treat seizures, nerve pain and restless leg syndrome might be linked with increased risk of dementia, a new...

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy

 Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases,...

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Latest FDA New Drug Approvals

  • Kirsty Kirsty (insulin aspart-xjhz) is a rapid acting human insulin analog interchangeable biosimilar to NovoLog (insulin aspart) indicated to...
  • Ekterly Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and...
  • Lynozyfic Lynozyfic (linvoseltamab-gcpt) is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager for the treatment of relapsed o...

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