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New medications coming soon: Here’s what’s been FDA approved in 2025 so far

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...
BioPharma Dive

Lilly, with new data, to seek FDA approval of obesity drug retatrutide

The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions ...

Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer

Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug ...

U.S. Food and Drug Administration Accepts BioMarin's Supplemental New Drug Application for Full Approval of VOXZOGO® (vosoritide) for Children With Achondroplasia

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO® ...
Precision Medicine Online

Arrowhead Seeking Approval for siRNA Drug for Severe Hypertriglyceridemia

The firm reported that two Phase III trials of Redemplo met their primary endpoints of lowering patients' triglyceride levels.

Jaguar Health Completes Submission of New Animal Drug Application for Full FDA Approval of Crofelemer for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs

Jaguar's recently completed pivotal effectiveness study of crofelemer for the treatment of CID in dogs demonstrates ...

Nicox’s NCX 470 New Drug Application Submitted in the United States by Kowa, with Associated €3 million Milestone Payment

Press Release Nicox’s NCX 470 New Drug Application Submitted in the United States by Kowa, with Associated €3 million Milestone PaymentNCX 470 ...

FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation

At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with ...
Forbes

New Pancreatic Cancer Drug Nearly Doubles Survival. Here’s What Patients Should Know

This voice experience is generated by AI. Learn more. This voice experience is generated by AI. Learn more. Former Senator Ben Sasse has become an unlikely public face of a drug that researchers are ...
RAPS

Study: China outpaces the US in cancer approvals, lags behind on first approvals

While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more first ...

BioMarin Pharmaceutical Inc.: U.S. Food and Drug Administration Accepts BioMarin's Supplemental New Drug Application for Full Approval of VOXZOGO (vosoritide) for Children With ...

Application based on long-term safety and efficacy data from three ongoing studies, including adult height and additional clinical outcomes beyond linear growth, including ...