US FDA approves first freeze-dried plasma product

By Siddhi Mahatole July 29 (Reuters) - The U.S. FDA on Wednesday approved the first freeze-dried plasma product for use in ...
Novartis

FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease

Pluvicto now approved across PSMA+ metastatic prostate cancer, nearly doubling eligible patient population; PSMAddition ...

Novartis Wins FDA Approval for Expanded Prostate Cancer Treatment For Pluvicto

"This approval signals a new era in the treatment of prostate cancer, representing a shift toward more targeted, early intervention," said Prostate Cancer Foundation Chief Executive Gina Carithers.

FDA approves long-lasting OTC pain reliever combining acetaminophen and naproxen

FDA approved Tylenol with Naproxen, the first OTC drug combining acetaminophen and naproxen sodium for up to 12 hours of pain relief.

FDA approves first-of-its-kind pain medication for long-lasting relief

Kenvue's Tylenol with Naproxen just became the first FDA-approved pill combining acetaminophen and naproxen sodium — two pain ...
MPR

FDA Grants Approval to Garzulys, a Rapid-Acting Insulin Biosimilar

FDA approves Garzulys (insulin aspart-fsan) as a rapid-acting biosimilar to NovoLog for adult and pediatric patients with diabetes mellitus.

FDA advisers support easing restrictions on six peptides. Here’s what those drugs are and what happens next

Peptides have become one of the hottest trends in wellness, with promises like faster muscle recovery and healthier aging.
Healio

FDA approves Gwyn Lo hormonal contraceptive patch with low-dose estrogen

The FDA approved a once-weekly combined hormonal contraceptive patch with low-dose estrogen for women who could become ...
Psychiatry Advisor

Simtriyo Gains FDA Approval as First NDSRI CNS Stimulant for ADHD

The FDA has approved Simtriyo (centanafadine), a first-in-class NDSRI and CNS stimulant, for adult and pediatric ADHD aged 6 years and older.
Healio

Cancer drug approvals increasingly based on surrogate endpoints, single-arm trials

An analysis of cancer medicines approved in the past couple decades to treat adults with solid tumors revealed what ...
Medscape

FDA Approves New Once-Weekly Birth Control Patch Gwyn Lo

The FDA has approved Gwyn Lo (Viatris), a new birth control patch that uses low-dose estrogen to prevent pregnancy.
The American Journal of Managed Care

FDA Advisory Panel Votes Against Approval of Deramiocel for DMD

CTGTAC concluded the evidentiary package did not substantiate clinical benefit for DMD cardiomyopathy, with multiple members characterizing the efficacy findings as statistically and clinically ...