SUBSCRIBE
SUBSCRIBE
News

FDA

Social media networking. Network with members connected with each other. Group of people. Communication, teamwork, community, society. Abstract concept with wooden pieces on blue background.
FDA
Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
February 13, 2026
 · 
6 min read
 · 
Heather McKenzie
FDA
FDA’s Prasad Weathers Personal Controversy, Internal Strife Amid Moderna Imbroglio
February 12, 2026
 · 
2 min read
 · 
Dan Samorodnitsky
3d rendering, Business e-mail. Open envelope with cross mark on sheet of paper. Rejected contract, document cancelled, not verified.
Editorial
All the Ways Moderna’s Flu Vaccine Rejection Letter Shocked Us
February 11, 2026
 · 
4 min read
 · 
Dan Samorodnitsky
Vaccines
FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies
February 11, 2026
 · 
4 min read
 · 
Tristan Manalac
Regulatory
Hims & Hers’ Woes Compound as FDA Hits Company With Warning Letter
February 10, 2026
 · 
2 min read
 · 
Tristan Manalac
Complete response letters
REGENXBIO’s Hunter Syndrome Gene Therapy Fails To Win FDA Nod
February 10, 2026
 · 
2 min read
 · 
Tristan Manalac
Opinion
2025 Reshaped the FDA. What Will 2026 Hold?
February 9, 2026
 · 
6 min read
 · 
Claire Davies
FEATURED STORIES
UFO looking like White house abducting a man. Conspiracy theory, paranoia afunny concept.Vector illustration.
Rare diseases
Despite Wide Support for Rare Disease, Voucher Program Caught Up in Senate’s ICE Fight
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
January 30, 2026
 · 
3 min read
 · 
Annalee Armstrong
RED pawn beating competition over white background. Standing out from the crowd. Business strategy, outsider becoming the leader.3D rendering on white background.
Rare diseases
Rare Disease Biotechs Stand To Lose $4B if Priority Voucher Program Not Reinstated: Report
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
January 26, 2026
 · 
7 min read
 · 
Heather McKenzie
Metaverse avatars of sandboxes games in virtual reality through VR goggles in the world of Metaverse 3D illustrations
Opinion
To Accelerate Rare Disease Progress, Take a Sandbox Approach
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
January 26, 2026
 · 
5 min read
 · 
Oxana Iliach
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Oxbryta gets greenlight for Pediatric SCD treatmen
FDA
FDA Greenlights Gilead/Kite’s Tecartus for Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
July 24, 2020
 · 
3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 27, 2020.
July 24, 2020
 · 
2 min read
 · 
BioSpace Editorial Staff
FDA
AstraZeneca Wins FDA Approval for COPD Treatment
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
July 24, 2020
 · 
2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 24
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 24, 2020.
July 23, 2020
 · 
4 min read
 · 
Editorial Staff
FDA
Jazz Pharma Wins FDA Approval for Lower-Sodium Narcolepsy Treatment
The U.S. Food and Drug Administration (FDA) approved Xywav, the first new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
July 22, 2020
 · 
2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: July 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 22, 2020.
July 21, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 20, 2020.
July 20, 2020
 · 
2 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 17, 2020.
July 16, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 15, 2020.
July 14, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
FDA
Janssen’s Tremfya Snags Approval as First IL-23 Treatment for Active Psoriatic Arthritis
In announcing the approval this morning, Janssen said IL-23 is a naturally occurring cytokine involved in normal inflammatory and immune responses associated with symptoms of psoriatic arthritis.
July 14, 2020
 · 
2 min read
 · 
Alex Keown
Load More