Capricor Therapeutics Announces FDA Advisory Committee Meeting to Review BLA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the Cellular, Tissue, and Gene ...

Key FDA committee unanimously recommends its first vaccine since 2023

All nine members of the committee unanimously voted to recommend Moderna's new mRNA influenza vaccine for adults 50 and over.
BioSpace

Capricor thrown for another loop as FDA sets adcomm for DMD cardiomyopathy therapy

The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told ...

Capricor falls as FDA sets up AdCom meeting to review Duchenne therapy

Capricor Therapeutics (CAPR) stock drops as the company faces an FDA advisory committee meeting in the review for its ...
Healio

FDA advisors back approval of mRNA flu shot

An FDA advisory committee voted unanimously on June 18 to recommend that a messenger RNA-based influenza vaccine at the center of a recent change of heart by the FDA be approved for older adults.In ...
The American Journal of Managed Care

ISPOR Panelists: Can the FDA Advisory Committee Process Be Strengthened?

Panelists at the leading health economics and outcomes conference discuss whether the FDA's process for allowing outside experts to weigh in on drug approvals needs changes. The share of drugs ...
CNN

FDA advisers weigh benefits of weekly insulin for people with diabetes

Most types of insulin therapy, an important part of diabetes treatment for many people, are given as daily injections to help manage blood sugar levels. Now, the maker of a once-weekly insulin ...
BioPharma Dive

Moderna flu vaccine wins unanimous support from FDA panel

The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to ...
Fierce Healthcare

FDA advisory committee to roll up sleeves on generative AI this week

The FDA has several advisory committees for topics within its regulatory purview. The independent experts offer advice and recommendations to the agency. (U.S. Food and Drug Administration) The FDA ...
RAPS

When FDA and Advisory Committees Disagree: Study Investigates Gaps

While only about one in five US Food and Drug Administration (FDA) new drug approvals or safety decisions run counter to outside advisory committee advice, a new study published Monday in the Milbank ...