FDA News: Approvals, Adcomms, Complete Response Letters and Guidances

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

FDA

FDA Approves Akili’s Therapeutic Video Game for ADHD

The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.

June 16, 2020

3 min read

Mark Terry

FDA

Jazz Pharma Gets Approval for Zepzelca in the U.S. for Aggressive Lung Cancer

The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.

June 16, 2020

3 min read

Mark Terry

FDA

FDA Cancels Emergency Use Authorization of Hydroxychloroquine for COVID-19

The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.

June 15, 2020

3 min read

Mark Terry

FDA

ViiV’s Tivicay Approved for Children as Young as 4 Weeks with HIV

The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay PD (dolutegravir) in combination with other antiretroviral drugs for children with HIV.

June 15, 2020

3 min read

Mark Terry

Policy

Biopharma Update on the Novel Coronavirus: June 15

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 15, 2020.

June 15, 2020

3 min read

BioSpace Editorial Staff

FDA

FDA Greenlight’s Viela Bio’s Uplizna for Rare Neuroinflammatory Autoimmune Disorder

The FDA approved Viela Bio’s Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive. About 80% of all NMOSD patients test positive for anti-AQP4 antibodies.

June 12, 2020

3 min read

Mark Terry