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FDA Grants Accelerated Approval to Lynozyfic (linvoseltamab-gcpt) for Treatment of Relapsed or Refractory Multiple Myeloma

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic...

Takeda Announces U.S. FDA Approval of Gammagard Liquid ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content

OSAKA, Japan and CAMBRIDGE, Massachusetts, June 30, 2025 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration...

FDA Approves Gamifant (emapalumab-lzsg) as First-Ever Treatment for Adults and Children with Macrophage Activation Syndrome in Still's Disease

Sobi today announced that the U.S. Food and Drug Administration (FDA) approved Gamifant (emapalumab-lzsg) for the treatment of adult and pediatric...

U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels for Breyanzi and Abecma

(BUSINESS WIRE) June 26, 2025 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved label...

Pediatric Mycoplasma Pneumoniae Infection Incidence Increased in 2024

Mycoplasma pneumoniae (M. pneumoniae)-associated community-acquired pneumonia (CAP) incidence was significantly higher in 2024 than in 2018 to 2023 among...

70 Percent Say They Would Conduct At-Home Test for Suspected COVID-19

Seventy percent of U.S. adults would conduct a home test for suspected COVID-19, according to a study published online June 30 in JAMA Network Open.Kimberly...

FDA Will Now Require Labeling of ADHD Medication to Indicate Weight Loss Risk

The U.S. Food and Drug Administration is revising the labeling of all extended-release attention-deficit/hyperactivity disorder (ADHD) medications, including...

2011 to 2023 Saw Increase in Prevalence of Obesity Among Children

The prevalence of obesity increased among children and adolescents from 2011 to 2023, with the increase most pronounced among Black youths, according to...

2023 to 2024 COVID-19 Vaccine Provided Additional Effectiveness

The 2023 to 2024 COVID-19 vaccine provided additional effectiveness against medically attended COVID-19, according to a study published online June 24...

Could Dairy Be Causing Your Bad Dreams?

WEDNESDAY, July 2, 2025 — Having bad dreams after eating ice cream or cheese? Your stomach may be trying to tell you something. New research shows...

Most Dads Take Two Weeks or Less of Parental Leave, Study Finds

WEDNESDAY, July 2, 2025 — Taking time off work when a baby is born is good for dads and babies alike. But a new study finds that most fathers still...

Judge Blocks Layoffs at U.S. Health Department

WEDNESDAY, July 2, 2025 — A federal judge has stopped the Trump administration from implementing more layoffs at the U.S. Department of Health and...

Hemispherian Receives U.S. FDA Orphan Drug Designation for GLIX1 for the Treatment of Malignant Glioma

Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S. Food and Drug...

FDA Requires Expanded Labeling About Weight Loss Risk in Patients Younger Than 6 Years Taking Extended-Release Stimulants for ADHD

FDA Drug Safety Communication - June 30, 2025 What safety concern is FDA announcing?The U.S. Food and Drug Administration (FDA) is revising the labeling...

Amgen Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-line Gastric Cancer

THOUSAND OAKS, Calif., June 30, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 FORTITUDE-101 clinical trial...

Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing...

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

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial. This single...

Body Fat Analysis, Waist Size Better Than BMI For Assessing Health

FRIDAY, June 27, 2025 — A person’s body fat percentage provides a better estimate of their risk for early death than their body mass index...

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Recently added consumer and prescribing information: Lynozyfic, Arynta, Harliku, Ibtrozi, Miudella, Opdivo Qvantig, Alyftrek, Crenessity, Ensacove, Steqeyma

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Latest FDA New Drug Approvals

  • Lynozyfic Lynozyfic (linvoseltamab-gcpt) is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager for the treatment of relapsed o...
  • Harliku Harliku (nitisinone) is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the reduction of urine homogentisic acid in adult...
  • Yeztugo Yeztugo (lenacapavir) is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor for pre‑exposure prophylaxis (PrEP) to reduce the r...

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