BioSpace

Disc’s FDA Rejection Raises Questions About Commissioner’s Vouchers

FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.

FDA Push for Nonprescription Drugs Risks Cost Shift to Consumers

The FDA’s call to industry to shift more prescription medications to over-the-counter stands to threaten drug coverage for patients as nonprescription products are generally excluded from health plans ...

FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
Yahoo

Extended interview: FDA chief calls warnings on menopause treatments an "American tragedy"

Add Yahoo as a preferred source to see more of our stories on Google. FDA Commissioner Dr. Marty Makary tells CBS News' Norah O'Donnell in an exclusive interview why the agency decided to drop decades ...

FDA reverses decision not to review Moderna’s new flu vaccine

The Food and Drug Administration has reversed its decision not to review a new flu vaccine from Moderna, the pharmaceutical company said Wednesday. Last week, the FDA sent a missive to Moderna ...
CURE

Expert Explains Yescarta Label Update in CNS Lymphoma

Primary CNS lymphoma is a rare and aggressive cancer with no FDA-approved treatments specific to the disease. While some ...

Pharma Seeks Relaxed FDA Oversight to Move Drugs to Over Counter

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to over-the-counter, a rigorous procedure that must demonstrate a patient no longer needs a ...
Fierce Pharma

FDA untitled letters target Novo’s 1st Wegovy pill ad and spots from argenx, Sobi

A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi. | A ...

FDA reverses course and will review Moderna’s mRNA-based flu shot

Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further study in older adults.
STAT

Moderna’s president weighs in on FDA’s decision not to review its flu vaccine

In an interview, Moderna President Stephen Hoge took questions on an FDA decision on the biotech's mRNA flu vaccine, as well as the impact on the company and others in the industry.
BioSpace

‘Just Agree to It:’ Pazdur Said He Was Told To Cosign FDA’s Reduced Trial Requirements

Richard Pazdur had spent 26 years at the FDA before stepping down last year due to disagreements with Commissioner Marty Makary about lowering the number of clinical trials required for a new drug ...
Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...