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FDA Grants Accelerated Approval for Voyxact (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) today announce the U.S. Food and Drug...

Imfinzi Approved in the US as First and Only Perioperative Immunotherapy for Patients with Early Gastric and Gastroesophageal Cancers

AstraZeneca’s Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel)...

FDA Approves Itvisma (onasemnogene abeparvovec-brve) Gene Replacement Therapy for Adults and Children Two Years and Older with Spinal Muscular Atrophy

Novartis today announced that the US Food and Drug Administration (FDA) has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of children...

FDA Approves Jubereq (denosumab-desu), a Biosimilar to Xgeva

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

FDA Approves Osvyrti (denosumab-desu), a Biosimilar to Prolia

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

FDA Grants Accelerated Approval to Hyrnuo (sevabertinib) for Non-Squamous Non-Small Cell Lung Cancer

Berlin, November 20, 2025 – Following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has...

Less Than One in Five Who Are Eligible Undergo Lung Cancer Screening

Less than 20 percent of screening-eligible individuals undergo lung cancer screening (LCS), according to a research letter published online Nov. 19 in...

Persistent Thyroid Hormone Imbalance During Pregnancy Tied to Heightened Autism Risk in Offspring

Women with persistent thyroid hormone imbalance across pregnancy may have an increased risk of having children with autism spectrum disorder (ASD), according...

Eight Trajectories of Long COVID Identified in U.S. Adults

Trajectories of long COVID have been identified, according to a study published online Nov. 17 in Nature Communications. Tanayott Thaweethai, Ph.D., from...

Grant Funding Disruptions Affect One in 30 Clinical Trials

Grant funding disruptions affected about one in 30 trials, according to a research letter published online Nov. 17 in JAMA Internal Medicine. Vishal R....

One Week Less on Social Media Linked to Better Mental Health

WEDNESDAY, Nov. 26, 2025 — For many young adults, social media is where life happens: Friendships, news, stress, all rolled into a single screen. But...

Your Brain Changes in Stages as You Age, Study Finds

WEDNESDAY, Nov. 26, 2025 — From childhood to old age, the human brain doesn’t just slowly fade or steadily grow, it changes in stages. A new...

Some Suicide Victims Show No Typical Warning Signs, Study Finds

WEDNESDAY, Nov. 26, 2025 — For many families who lose someone to suicide, the same question comes up again and again: “How did we not see this...

ByHeart Formula Faces Lawsuits After Babies Sickened With Botulism

WEDNESDAY, Nov. 26, 2025 — Several families have filed lawsuits against infant formula maker ByHeart, claiming its contaminated formula caused their...

Evoke Phase 3 Oral Semaglutide Trials Did Not Demonstrate a Statistically Significant Reduction in Alzheimer's Disease Progression

Bagsværd, Denmark, 24 November 2025 – Novo Nordisk today announced the top-line results from the 2-year primary analysis of evoke and...

Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention

Berlin, November 23, 2025 – Bayer today announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational,...

Three Times As Many Lung Cancer Deaths Could Be Prevented With One Simple Step

FRIDAY, Nov. 21, 2025 — Three times as many lung cancer deaths could be prevented if everyone eligible for screening got a chest CT scan, a new study...

FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura

FDA Safety Communication – November 21, 2025 Summary of the Issue Since approval, the Food and Drug Administration (FDA) has received postmarketing...

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Latest FDA New Drug Approvals

  • Voyxact Voyxact (sibeprenlimab-szsi) is an A Proliferation Inducing Ligand (APRIL) blocker indicated to reduce proteinuria in adults with primary...
  • Itvisma Itvisma (onasemnogene abeparvovec-brve) is an adeno-associated virus (AAV) vector-based gene therapy for the treatment of spinal muscular atrophy.
  • Jubereq Jubereq (denosumab-desu) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related...

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