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FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial Infections
(BUSINESS WIRE) September 25, 2023 -- Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical...
US FDA Approves Jardiance for the Treatment of Adults with Chronic Kidney Disease
RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 22, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin)...
Reviva Announces Last Patient Evaluated in Pivotal Phase 3 RECOVER Trial for Brilaroxazine in Schizophrenia
CUPERTINO, Calif., Sept. 25, 2023. Reviva Pharmaceuticals Holdings, Inc. (“Reviva” or the “Company”), a late-stage pharmaceutical...
37 Percent Diagnosed With Type 1 Diabetes After Age 30
Diagnosis of type 1 diabetes often occurs after age 30 years, more so in men and racial/ethnic minorities, according to a research letter published online...
Nirmatrelvir, Molnupiravir Use Lowers Risks for Omicron-Infected
For patients infected with omicron at high risk for progression to severe disease, treatment with nirmatrelvir or molnupiravir is associated with reductions...
Family History Influences Penetrance of Hereditary Cancers
For individuals with a pathogenic variant in the major genes responsible for hereditary breast cancer or Lynch syndrome, having a first-degree family history...
Surgeons Perform Transplant of Gene-Tweaked Pig Heart Into Second Patient
A second human patient has received a genetically altered pig heart as he battles the ravages of end-stage heart disease. The 58-year-old man, Lawrence...
Experiment Shows Many Seniors Falling Prey to 'Impostor Scams'
Many older adults are savvy about telephone scams, but a sizable minority remain vulnerable, a new study suggests. Researchers found that when they simulated...
Heat-Related Deaths Could Break Records This Year in Phoenix, America's Hottest City
Phoenix, already the hottest major city in the nation, experienced its most scorching summer on record this year, new data shows. And that will likely...
Breast Cancer Drug, Piqray, Could Trigger Dangerous High Blood Sugar
For certain patients with advanced breast cancer, a drug called Piqray (alpelisib) may extend survival. But new research confirms the medication often...
Playtime With Dad Brings Kids Better Grades at School
Most parents want to help their kids do well in school, and for dads the answer may be found in something simple and fun. A new study from the United...
FDA Accepts Submission to Add PH-ILD to Yutrepia™ Label
Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s...
Datopotamab Deruxtecan Demonstrated Statistically Significant and Clinically Meaningful Progression-Free Survival Benefit in Patients with HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial
Positive high-level results from the TROPION-Breast01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant...
VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus
September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer...
Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile
Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile. The FDA has identified this as...
Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)
OSAKA, Japan and CAMBRIDGE, Massachusetts, September 20, 2023 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration...
UCB Provides Update on U.S. Regulatory Review of Bimekizumab
Brussels (Belgium), 19 September 2023 – UCB, a global biopharmaceutical company, today provided an update on the Biologics License Application (BLA)...
FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study
Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced...
Using Meds to Manage Your Arthritis Pain: An Overview
Millions of Americans suffer from arthritis, and many reach for medication to ease their joint pain and inflammation. The options might seem overwhelming,...
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Latest FDA New Drug Approvals
- Likmez Likmez (metronidazole) is an oral liquid suspension formulation of the approved antibiotic metronidazole for the treatment of parasitic and...
- Ojjaara Ojjaara (momelotinib) is a JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor for the treatment of myelofibrosis patients with anemia.
- Aphexda Aphexda (motixafortide) is a hematopoietic stem cell mobilizer indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic...
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.