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FDA Approves Beqvez (fidanacogene elaparvovec-dzkt) One-Time Gene Therapy for Adults with Hemophilia B
(BUSINESS WIRE) April 26, 2024 -- Pfizer Inc. (NYSE: PFE)announced today that the U.S. Food and Drug Administration (FDA) has approved Beqvez™ (fidanacogene...
FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract Infections
Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract...
Novartis Radioligand Therapy Lutathera FDA Approved as First Medicine Specifically for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Lutathera (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide)...
FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma
Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated...
FDA Approves Anktiva (nogapendekin alfa inbakicept-pmln) Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has approved Anktiva...
Lower Dose of Mpox Vaccine is Safe and Generates Six-Week Antibody Response Equivalent to Standard Regimen
A dose-sparing intradermal mpox vaccination regimen was safe and generated an antibody response equivalent to that induced by the standard regimen at six...
Two-Thirds of Survivors of the Most Severe COVID-19 Face Impairment at One Year
Nearly two-thirds of survivors of severe COVID-19 discharged to long-term acute care hospitals have persistent impairments at one year, according to a...
Births in the United States Declined in 2023
In 2023, birth rates in the United States were down, according to an April Vital Statistics Rapid Release provisional report, a publication from the National...
Serum Biomarkers Predict Knee OA Before Radiographic Abnormalities
Serum biomarkers can predict knee osteoarthritis before radiographic abnormalities, according to a study published in the April 26 issue of Science Advances....
Antenatal Corticosteroids Do Not Negatively Impact Offspring
Administration of antenatal corticosteroids to persons at risk for late preterm delivery is not associated with adverse childhood neurodevelopmental outcomes...
USDA Gets Tougher on Salmonella in Raw Breaded Chicken Products
The U.S. Department of Agriculture is clamping down on salmonella bacteria found in breaded, stuffed raw chicken products, with the agency issuing a final...
'Drug Take Back Day' is Saturday: Check for Leftover Opioids in Your Home
Each year, thousands of Americans head home after a surgery clutching prescription opioids to help ease post-surgical pain. Trouble is, most won't use...
Fragments of Bird Flu Virus Found in 1 in 5 Milk Samples
Bits of bird flu virus have been discovered in roughly 20% of retail milk samples tested in a national survey, the U.S. Food and Drug Administration said...
Clients Got HIV Through 'Vampire Facial' Microneedling Treatments
Between 2018 and the spring of 2023, a cluster of clients who had gotten 'vampire facial' microneedling skin treatments at a New Mexico spa were diagnosed...
Which Patients and Surgeries Are 'High Risk' for Seniors?
Most seniors probably view any emergency surgery with a certain level of anxiety. Now, a new study seeks to sort out who might be at highest risk for...
Analysis Identifies 50 New Genomic Regions Associated with Kidney Cancer Risk
In a new analysis of genetic susceptibility to kidney cancer, an international team of researchers has identified 50 new areas across the genome that are...
Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy's Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots...
Stop Clopez Corp. Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil
April 22, 2024– Hollywood, FL, US, Stop Clopez Corp. is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has...
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Recently added consumer and prescribing information: Pivya, Xromi, Risvan, Voydeya, Winrevair, Pemgarda, Tryvio, Edurant and Edurant Ped, Tevimbra, Rezdiffra
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Latest FDA New Drug Approvals
- Beqvez Beqvez (fidanacogene elaparvovec-dzkt) is an adeno-associated virus vector-based gene therapy for the treatment of adults with moderate to...
- Pivya Pivya (pivmecillinam) is a penicillin class antibacterial for use in the treatment of uncomplicated urinary tract infections.
- Ojemda Ojemda (tovorafenib) is a type II pan-RAF kinase inhibitor for the treatment of pediatric low-grade glioma.
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...
- Libervant Libervant (diazepam) is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters.