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
lucarista / Shutterstock
FDA
New Roche Diagnostics Device Tests Levels of IL-6 in COVID-19 Patients
Instead of detecting the virus, this device can help determine who might be at risk for intubation and mechanical ventilation.
June 4, 2020
 · 
2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: June 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 4, 2020.
June 4, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
FDA
FDA Delays Ruling on Novartis’ Relapsing Multiple Sclerosis Drug Arzerra
On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months.
June 3, 2020
 · 
2 min read
 · 
Alex Keown
Drug Development
Biopharma Update on the Novel Coronavirus: June 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 3, 2020.
June 3, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Oriahnn is the new non-surgical treatment for heav
FDA
FDA Approves New Treatment Oriahnn for Heavy Menstrual Bleeding Associated with Uterine Fibroids
AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
June 1, 2020
 · 
2 min read
 · 
Alex Keown
FDA
Genentech’s Tecentriq-Avastin Combo Approved for HCC, an Improvement on Standard of Care
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
June 1, 2020
 · 
3 min read
 · 
Mark Terry
FDA
FDA Approves Lilly’s Tauvid Imaging Agent to Help Diagnose Alzheimer’s Disease
Tauvid is the first and only approved diagnostic agent for imaging tau neurofibrillary tangles (NFTs) in the brain.
May 29, 2020
 · 
3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: June 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 1, 2020.
May 28, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 29, 2020.
May 28, 2020
 · 
2 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 28, 2020.
May 28, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
Load More