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

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Opinion

Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.

April 24, 2026

5 min read

Joshua R. Mansbach

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Gene therapy

FDA approval of Regeneron’s hearing loss gene therapy breaks barriers

April 23, 2026

4 min read

Heather McKenzie

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Manufacturing

FDA issues warning letter after GLP-1 manufacturer refuses inspectors access

April 22, 2026

2 min read

Nick Paul Taylor

Psychedelics

Trump’s psychedelics push a mixed blessing for neuropsychiatric companies, patients

April 22, 2026

8 min read

Heather McKenzie

Approvals

Merck steps up as ‘meaningful competitor’ to Gilead with HIV pill approval

April 22, 2026

1 min read

Tristan Manalac

Policy

FDA Policy Tracker 2026: Psychedelics get a boost

April 20, 2026

10 min read

BioSpace Editorial Staff

FDA

Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA

April 17, 2026

5 min read

Heather McKenzie

FEATURED STORIES

FDA

Deep dive: Checking in with the FDA

BioSpace looks back at 2025 and where the FDA is going in 2026.

April 15, 2026

2 min read

Heather McKenzie

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Regulatory

FDA flexibility isn’t absent but evolving regulations come with growing pains

The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.

April 13, 2026

5 min read

Heather McKenzie

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FDA

FDA’s CRL transparency policy is boosting biopharma accountability

Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.

April 13, 2026

5 min read

Nick Paul Taylor

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THE LATEST

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