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Bavarian Nordic Receives U.S. FDA Approval of Jynneos Freeze-Dried Smallpox and Mpox Vaccine

COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved...

FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A or B With or Without Inhibitors

Paris, March 28, 2025. The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine...

FDA Approves Imfinzi (durvalumab) for Muscle Invasive Bladder Cancer

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment,...

FDA Approves Novartis Radioligand Therapy Pluvicto for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Basel, March 28, 2025 – Novartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan)...

FDA Approves Conexxence (denosumab-bnht), a Biosimilar to Prolia

Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilar Conexxence (denosumab-bnht) of its operating company Fresenius...

FDA Approves Vykat XR (diazoxide choline) to Treat Hyperphagia in Prader-Willi Syndrome

REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing...

Combination Immunotherapy Shrank a Variety of Metastatic Gastrointestinal Cancers

A new form of tumor infiltrating lymphocyte (TIL) therapy, a form of personalized cancer immunotherapy, dramatically improved the treatment’s effectiveness...

FDA Approves First At-Home Test to Diagnose Three STIs in Women

 The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea,...

Common Photosensitizing Drugs Increase Skin Cancer Risk

Some commonly prescribed photosensitizing drugs increase skin cancer risk, according to a study published online March 18 in Photodermatology, Photoimmunology...

Similar Efficacy Seen for Isodose, Dose-Escalated MHFRT, CFRT in Prostate Cancer

For patients with prostate cancer, isodose and dose-escalated moderately hypofractionated radiotherapy (MHFRT) have similar efficacy as conventionally...

AI Model Can Optimize, Standardize Total Parenteral Nutrition Formulas

An artificial intelligence (AI) approach identified total parenteral nutrition (TPN) formulas that increase safety and potentially reduce costs for neonates...

Subclinical Cardiac Dysfunction Linked to Markers of Neurodegeneration

Subclinical cardiac dysfunction is associated with brain imaging markers of neurodegeneration, according to a study published online March 26 in Neurology. Amber...

Experts Concerned as NIH Axes Critical Vaccine Study Funds

Hundreds of U.S. research projects aimed at boosting vaccine confidence have been shut down -- just as preventable diseases like measles and flu are on...

Brain Implant Lets Woman Talk After 18 Years of Silence Due to Stroke

For nearly two decades, a stroke had left a woman unable to speak -- until now.  Thanks to a new brain implant, her thoughts are being turned into...

Major Job Cuts at NIOSH Pose Risks to Worker Safety, Critics Warn

A major round of job cuts at the National Institute for Occupational Safety and Health (NIOSH) could weaken efforts to protect American workers, according...

Vanda Pharmaceuticals Announces the Submission of an NDA to the FDA for Bysanti for the Treatments of Acute Bipolar I Disorder and Schizophrenia

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration...

Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

PRINCETON, N.J. and TOKYO, JAPAN March 31, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co.,...

Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

(BUSINESS WIRE)--Mar. 31, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development...

FDA Issues Complete Response Letter for Etripamil for PSVT

MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced the U.S....

Sugar Substitute Appears To Boost Appetite, Hunger

Splenda doesn’t directly add calories to your diet, but the sweetener still might lead people to pack on pounds, a new study says. The sugar substitute...

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Latest FDA New Drug Approvals

  • Qfitlia Qfitlia (fitusiran) is an antithrombin-directed small interfering ribonucleic acid for the prophylactic treatment of people with hemophilia...
  • Bomyntra Bomyntra (denosumab-bnht) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related...
  • Conexxence Conexxence (denosumab-bnht) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.

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