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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 Bomyntra (denosumab-bnht), a Biosimilar to Xgeva

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

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...

FDA Approves Blujepa (gepotidacin) for the Treatment of Uncomplicated Urinary Tract Infections

25 March 2025 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment...

FDA Approves Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) for Prostate Cancer Imaging

Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx,...

Citrus Oil Formula May Relieve Dry Mouth for Cancer Patients

A new formula made with natural citrus oil could help cancer patients find relief from dry mouth, a common and painful side effect of radiation treatments.The...

Utah Becomes First State to Ban Community Water Fluoridation

With a new law, signed by Gov. Spencer Cox on March 27, Utah has become the first U.S. state to ban the addition of fluoride to public drinking water,...

Combination Lipid-Lowering Therapy Linked to Greater Drop in LDL-C

Combination lipid-lowering therapy (LLT) is associated with a greater reduction in low-density lipoprotein cholesterol (LDL-C) compared with statin monotherapy,...

Many Women Undergo Annual Mammography, Despite Biennial Screening Recommendations

A high proportion of women seem to undergo mammography screening every year, despite recommendations for biennial screening, according to a research letter...

Adverse Outcomes Increased With Long-Term Inhaled Corticosteroids in COPD

For patients with chronic obstructive pulmonary disorder (COPD), long-term inhaled corticosteroid (ICS) treatment is associated with increased rates of...

Consensus Guidance Lays Out Recommendations for Postpartum Physical Activity

New mothers are encouraged to engage in two hours per week of exercise, according to a consensus guideline published online March 25 in the British Journal...

Organ Transplant Patient Dies After Contracting Rabies

A Michigan resident has died after receiving an organ transplant infected with rabies, state health officials said Wednesday. The patient got the transplant...

Measles Outbreak Leads to Dangerous Vitamin A Toxicity

As a measles outbreak spreads across U.S., doctors are now seeing a new and unexpected danger: Children getting sick from taking too much vitamin A. At...

Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) Keytruda® (pembrolizumab) in Pivotal 3475A-D77 Trial

(BUSINESS WIRE) March 27, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first data presentation...

Chlamydia Vaccine Candidate Granted Fast Track Designation by the US FDA

Paris, March 26, 2025. The US Food and Drug Administration has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention...

This Diet Is Best For Healthy Aging

How should a person eat in middle age to protect their health as they grow older? One diet came out a clear winner in a 30-year study involving more than...

FDA Grants Priority Review for Biologics License Application (BLA) for Apitegromab as a Treatment for Spinal Muscular Atrophy

(BUSINESS WIRE)--Mar. 25, 2025-- Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular...

Tolebrutinib Regulatory Submission Accepted for Priority Review in the US for Patients with Multiple Sclerosis

Paris, March 25, 2025. The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib...

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Latest FDA New Drug Approvals

  • 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.
  • Vykat XR Vykat XR (diazoxide choline) is an extended-release formulation of the crystalline salt of diazoxide for use in the treatment of...

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