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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...
U.S. FDA Approves Subcutaneous Administration of Takeda’s Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease
OSAKA, Japan April 19, 2024 and CAMBRIDGE, Massachusetts, April 18, 2024 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug...
FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-Lumpectomy
(BUSINESS WIRE) April 18, 2024 --Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for...
FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer
April 18, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration...
Mortality Up for Breast Cancer Diagnosed Five to
Young-onset breast cancer (YOBC) with germline BRCA pathogenic variants (PVs) is associated with an increased risk for all-cause mortality if diagnosed...
GLP1 Receptor Agonist Use Does Not Seem to Increase Risk for Thyroid Cancer
Glucagon-like peptide 1 (GLP1) receptor agonist use does not appear to be associated with an increased risk for thyroid cancer, according to a study published...
Noninvasive Imaging Aids Selection of Stenosis Patients Needing Revascularization Procedure
Computed tomography fractional flow reserve (CT-FFR) improves assessment of vessel blockages and reduces the number of stenosis patients referred for invasive...
Seafood Consumption Tied to 'Forever Chemical' Exposure Risk
Northeastern U.S. seafood consumers may be exposed to per- and polyfluoroalkyl substance (PFAS) concentrations that potentially pose a health risk, according...
Patient Gets First-Ever Pig Kidney Transplant Plus Heart Pump
New Jersey native Lisa Pisano was staring down the end of her days.The 54-year-old had heart failure and end-stage kidney disease, but several chronic...
Almost 40% of Americans Live With Dirty Air: Report
Nearly 40% of Americans live where the air is polluted enough to harm them, a new report warns.In the American Lung Association's “State of the Air”...
Fragments of Bird Flu Virus Found in U.S. Milk Supply
Bits of inactive bird flu virus have been discovered in samples of pasteurized milk from across the United States, health officials said Tuesday, although...
There's an 'Epidemic' of Loneliness Among U.S. Parents, Poll Finds
Anne Helms is one busy mom, constantly juggling the demands of working from home with parenting two young children.Despite that whirl of activity, Helms...
Endevica Bio drug candidate shows success in weight loss in new study
NORTHBROOK, Ill., April 23, 2024 - Endevica Bio, a company developing first-in-class peptide drug candidates, announced its novel weight-loss treatment...
Neosporin Ointment in the Nose Might Be Potent Antibiotic
Want to prevent a respiratory infection? A fingerful of Neosporin antibiotic swabbed inside your nose might help you fight off a range of invading respiratory...
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...
FDA Approves Clinical Trial for GFH925 Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer
SHANGHAI, April 19, 2024. GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology,...
Abeona Therapeutics Provides Regulatory Update on Pz-cel
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration...
FDA Requires Boxed Warning for T Cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous CAR T Cell Immunotherapies
In November 2023, the Food and Drug Administration (FDA) posted a safety communication to provide information about reports of T cell malignancies including...
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Latest FDA New Drug Approvals
- Anktiva Anktiva (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 superagonist for use in combination with Bacillus...
- Lumisight Lumisight (pegulicianine) is an optical imaging agent for the detection of residual cancerous tissue during breast cancer surgery.
- Selarsdi Selarsdi (ustekinumab-aekn) is a human interleukin-12 and -23 antagonist biosimilar to Stelara used for the treatment of plaque psoriasis...
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.