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U.S. FDA Approves Kerendia (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority Review
WHIPPANY, N.J., July 14, 2025 – Bayer today announced that the U.S. Food and Drug Administration (FDA) approved Kerendia (finerenone) to treat patients...
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease
CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration...
FDA Approves Updated Label for Lilly's Kisunla (donanemab-azbt) with New Dosing in Early Symptomatic Alzheimer's Disease
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label update with a new recommended titration...
FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)
CAMBRIDGE, Mass. & SALISBURY, England, July 7, 2025 (BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food...
ENDO: Superior Weight Loss Seen With Tirzepatide and Menopausal Hormone Therapy Use
In postmenopausal women with overweight or obesity receiving tirzepatide, use of menopausal hormone therapy (MHT) is associated with superior weight loss...
ENDO: Sweeteners, Genetic Predisposition Independently Linked to Early Puberty
Sweetener consumption and genetic predisposition are independently associated with the risk for central precocious puberty (CPP), according to a study...
Skin Prick Automated Test Shows Equivalent Accuracy to Conventional Skin Prick Test
Compared with the conventional skin prick test (SPT), the novel Skin Prick Automated Test (SPAT) shows equivalent accuracy to detect birch pollen or house-dust...
Cell Therapy MDR-101 Produces Functional Immune Tolerance in Kidney Transplant Recipients
Kidney transplant recipients receiving the investigational cellular product MDR-101 achieved functional immune tolerance for more than two years, according...
Study Finds No Link Between Vaccine Aluminum and Health Problems
TUESDAY, July 15, 2025 — A new study of more than 1.2 million people found no link between aluminum in childhood vaccines and long-term health problems,...
Most Major Ice Cream Brands Will Remove Synthetic Dyes by 2028
TUESDAY, July 15, 2025 — About 90% of the ice cream sold in the U.S. will no longer contain artificial dyes by 2028, federal health officials announced. Roughly...
FDA Approves Gardenia-Based Blue Dye for Use in Foods and Drinks
TUESDAY, July 15, 2025 — A natural blue food coloring made from gardenia fruit has been approved by the U.S. Food and Drug Administration (FDA). The...
Vaping Better At Helping Smokers Quit, Clinical Trial Indicates
TUESDAY, July 15, 2025 — Vaping might be more effective than traditional nicotine replacement therapies in helping people quit smoking, a new Australian...
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
UPDATE July 14, 2025 – Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin...
Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1
OSAKA, Japan and CAMBRIDGE, Massachusetts, July 14, 2025 – Takeda (TSE:4502/NYSE:TAK) today announced that all primary and secondary endpoints...
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry
Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company...
Popular Chronic Pain Med, Gabapentin, Linked To Dementia Risk
FRIDAY, July 11, 2025 — A drug used to treat seizures, nerve pain and restless leg syndrome might be linked with increased risk of dementia, a new...
Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases,...
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Recently added consumer and prescribing information: Zegfrovy, Lynozyfic, Arynta, Harliku, Ibtrozi, Miudella, Opdivo Qvantig, Alyftrek, Crenessity, Ensacove
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Latest FDA New Drug Approvals
- Ekterly Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and...
- Lynozyfic Lynozyfic (linvoseltamab-gcpt) is a bispecific B-cell maturation antigen (BCMA)‑directed CD3 T-cell engager for the treatment of relapsed o...
- Zegfrovy Zegfrovy (sunvozertinib) is an oral, irreversible, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the...