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US FDA Approves GSK’s Shingrix in a Prefilled Syringe Presentation

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix (GSK’s...

5 days ago New Drug Approvals

FDA Approves Kirsty (insulin aspart-xjhz), an Interchangeable Biosimilar to NovoLog

BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India: July 15, 2025 -- Biocon Biologics Ltd (BBL), a fully integrated global...

6 days ago New Drug Approvals

Dementia Risk Does Not Differ With GLP-1 RAs, DPP4is for Seniors With T2DM

For older adults with diabetes, there is no clear evidence to suggest that the incidence of dementia differs for those using glucagon-like peptide 1 receptor...

today News for Health Professionals

Urgent Care Visits Often Linked to Inappropriate Prescribing

Urgent care visits are often associated with inappropriate prescriptions of antibiotics, glucocorticoids, and opioids, according to a research letter published...

today News for Health Professionals

Johnson & Johnson Seeks First Icotrokinra U.S. FDA Approval Aiming to Revolutionize Treatment Paradigm for Adults and Adolescents with Plaque Psoriasis

SPRING HOUSE, Pa. (July 21, 2025) – Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA)...

today New Drug Applications

FDA Approves Prefilled Syringe Presentation for Shingles Vaccine

The U.S. Food and Drug Administration has approved a prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention...

today Medical

Race Definitions Have Limited Impact on Cancer Rates in Whites, Blacks, Asians

Race definitions have limited impact on cancer rates for Whites, Blacks, and Asians, but do impact rates in multiracial individuals, according to a study...

today News for Health Professionals

Cannabis Use Disorder May Up Risk of Benign Salivary Gland Tumors

Cannabis use disorder (CUD) is associated with increased risk of benign salivary gland tumors, according to a research letter published online July 17...

today News for Health Professionals

FDA Elevates Dubai Chocolate Spread Recall to Class 1 Over Salmonella Risk

MONDAY, July 21, 2025 — The U.S. Food and Drug Administration (FDA) has escalated the recall of a popular Dubai chocolate spread sold nationwide...

today Medical

GI Cancers On The Rise Among Younger Adults

MONDAY, July 21, 2025 — GI cancers among people 50 and younger are rising at an alarming rate, increasing in the U.S. faster than any other type...

today Medical

Eggs Guilt-Free For 'Bad' Cholesterol, Experiment Shows

MONDAY, July 21, 2025 — A new egg study has produced sunny-side-up results for the oft-maligned breakfast staple. Eggs are commonly thought to increase...

today Medical

Genentech Provides Update on Astegolimab in Chronic Obstructive Pulmonary Disease

July 20, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today topline results from the pivotal Phase IIb ALIENTO...

2 days ago Clinical Trials

FDA Investigating Deaths Due to Acute Liver Failure Following Treatment with Sarepta’s AAVrh74 Gene Therapies

As of July 18, 2025, the Food and Drug Administration (FDA) has received three reports of fatal acute liver failure following treatment of patients with...

3 days ago FDA Alerts

FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following Three Deaths

The U.S. Food and Drug Administration today announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular...

4 days ago Clinical Trials

Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease

(BUSINESS WIRE)--Jul. 17, 2025-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA)...

4 days ago New Drug Applications

Doctors Overlooking Common Cause Of High Blood Pressure, New Guidelines Say

WEDNESDAY, July 16, 2025 — Doctors are regularly overlooking a common hormone-driven cause of high blood pressure, a new paper warns. As many as...

5 days ago Medical

FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine

The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine,...

6 days ago FDA Alerts

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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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Kirsty Kirsty (insulin aspart-xjhz) is a rapid acting human insulin analog interchangeable biosimilar to NovoLog (insulin aspart) indicated to...
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...

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FDA Investigating Deaths Due to Acute Liver Failure Following Treatment with Sarepta’s AAVrh74 Gene Therapies

FDA Approves Kirsty (insulin aspart-xjhz), an Interchangeable Biosimilar to NovoLog

GI Cancers On The Rise Among Younger Adults

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