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FDA Approves Kisunla (donanemab-azbt) for the Treatment of Early Symptomatic Alzheimer's Disease

The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and...

FDA Approves Ahzantive (aflibercept-mrbb), a Biosimilar to Eylea

Planegg-Martinsried, Germany July 1, 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”)...

FDA Approves Pyzchiva (ustekinumab-ttwe), a Biosimilar to Stelara

Basel, July 1, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA)...

FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer

(BUSINESS WIRE) June 28, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S....

FDA Approves Ohtuvayre (ensifentrine) for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

LONDON and RALEIGH, N.C., June 26, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”),...

FDA Approves New Drug to Treat Alzheimer's

A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday.In clinical trials, donanemab (Kisunla) modestly...

U.S. Government to Pay Moderna $176 Million to Develop mRNA Flu Vaccine

U.S. health officials announced Tuesday that the federal government will pay Moderna $176 million to speed development of a pandemic flu vaccine based...

Mean Cost of Bringing New Drug to U.S. Market Is $879.3 Million

The mean cost of developing a new drug for the U.S. market is estimated to be $879.3 million when both drug development failure and capital costs are considered,...

High Social Media Use Tied to Depression in Only Some Teens

High social media use is only tied to increased depression in teens who are already vulnerable, according to a study published online June 26 in the Journal...

Patient–Primary Care Provider Language Concordance Tied to Better Outcomes

Patient-family physician language concordance is associated with a lower risk for adverse outcomes, according to a study published online June 3 in BMJ...

Self-Administered Gerocognitive Exam Improves Detection of Cognitive Issues in Primary Care

A self-administered gerocognitive examination (SAGE) is easily incorporated into primary care provider (PCP) visits, and its use significantly increases...

Supreme Court to Hear Case Challenging FDA's Ban of Flavored Vapes

In a case that will test the U.S. Food and Drug Administration's authority to approve or reject new vaping products, the U.S. Supreme Court said Tuesday...

Tattoo Inks Can Be Contaminated With Bacteria: Study

TUESDAY, July 2, 2024 — Getting inked could make you sick. In a first-of-its-kind study, researchers detected bacteria in commercial tattoo and...

Phase 1 Clinical Trial of PMC-403 for Neovascular Age-related Macular Degeneration Advances to Both Single-dose of 4mg and Multiple-dose of 3mg

DAEJEON, South Korea, July 2, 2024. PharmAbcine, Inc. ("PharmAbcine" or the "Company") (KOSDAQ: 208340), a clinical-stage public company developing next...

SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today...

Monthly News Roundup - June 2024

FDA Grants Expanded Approval to Skyrizi for Ulcerative Colitis On June 18th, the U.S. Food and Drug Administration (FDA) approved AbbVie’s Skyrizi...

Sirnaomics Announces Completion of STP707 Phase I Clinical Study with Strong Safety Profile and Disease Activity for the Treatment of Pancreatic Cancer Patients

HONG KONG, GERMANTOWN, Md. and SUZHOU, China, June 28, 2024  Sirnaomics Ltd. (the "Company", together with its subsidiaries, the "Group" or "Sirnaomics";...

Scientists Spot Which Gut Germs Trigger Compulsive Eating

Specific types of gut bacteria appear to be linked to compulsive eating, a new study reports. Researchers found that one type of gut bacteria -- the Proteobacteria...

Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System

Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare...

Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for...

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Latest FDA New Drug Approvals

  • Kisunla Kisunla (donanemab-azbt) is an amyloid beta-directed antibody indicated for the treatment of early symptomatic Alzheimer’s disease.
  • Ahzantive Ahzantive (aflibercept-mrbb) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea indicated for the treatment of...
  • Pyzchiva Pyzchiva (ustekinumab-ttwe) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis...

More FDA approvals

Drugs in Development (Not yet approved)

  • Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...

More drugs in development