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

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Gene therapy

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

Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.

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

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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

FDA

Drug pricing watchdog calls for increased transparency into FDA’s accelerated approval decisions

April 16, 2026

4 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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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