article thumbnail

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations

Fierce Pharma

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

FDA 363
article thumbnail

How Will FDA Guidance Impact Decentralized Clinical Trials in 2023?

MedCity News

The FDA is trying to tell these companies what it wants to be different in trials across the board with regards to digital health endpoints, the use of real-world data (RWD) as regulatory-grade data, and diversity in clinical trial inclusion. The agency’s goal is to spur a macro shift in clinical trials.

FDA 307
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

FDA 357
article thumbnail

Drug Approvals in 2022: A Recap of Notable FDA Regulatory Decisions

MedCity News

Fewer new drugs won FDA approvals in 2022 compared to previous years, but some of the products that passed regulatory muster are indicative of trends expected to continue into 2023. For example, more gene and cell therapies are on track to face regulatory decisions in the coming year.

FDA 326
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. Explore the limitations of what we know about prescription drug dosing The future of Clinical Research April 12, 2023 at 11:00 am PDT, 2:00 pm EDT, 7:00 pm GMT What will the future hold for clinical research?

article thumbnail

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv

Fierce Pharma

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

FDA 314
article thumbnail

2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line

Fierce Pharma

2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line. Sun, 12/18/2022 - 17:18.

Pharma 239