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

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Rare diseases

Through flux and fluidity, FDA keeps coming back to rare disease

Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.

July 8, 2026

6 min read

Heather McKenzie

Manufacturing

Amgen recalls almost 1 million bottles of heart failure drug over quality issue

July 8, 2026

1 min read

Nick Paul Taylor

Podcast

Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil

July 8, 2026

1 min read

Jef Akst

Approvals

Vera moves into growing kidney disease space with FDA’s accelerated IgAN nod

July 7, 2026

2 min read

Annalee Armstrong

Opinion

The FDA must put biotech at its center or continue to cede early research to China

July 6, 2026

4 min read

Kendalle Burlin O’Connell

FDA

Despite chaos and churn, FDA decisions hold mostly steady in H1 2026

July 6, 2026

8 min read

Tristan Manalac

Editorial

Biotech’s China problem: An issue of national security or economic value for the US?

July 2, 2026

6 min read

Jef Akst

FEATURED STORIES

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Huntington’s disease

Skyhawk CEO hopes FDA’s new uniQure position will translate to Huntington’s pill

A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.

June 30, 2026

4 min read

Heather McKenzie

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Duchenne muscular dystrophy

Capricor thrown for another loop as FDA sets adcomm for DMD cardiomyopathy therapy

The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.

June 26, 2026

4 min read

Heather McKenzie

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Opinion

The hidden cost of FDA unpredictability

When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.

June 26, 2026

6 min read

David Crean

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THE LATEST

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