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

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Manufacturing

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.

January 13, 2026

5 min read

Nick Paul Taylor

Regulatory

FDA Carves Out Manufacturing Exemptions for CGTs To Accelerate Development

January 12, 2026

2 min read

Tristan Manalac

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FDA

6 FDA Decisions To Watch in Q1 2026

January 12, 2026

8 min read

Tristan Manalac

Complete response letters

Vanda Slides After FDA Again Rejects Hetlioz For Jet Lag

January 8, 2026

2 min read

Dan Samorodnitsky

Multiple sclerosis

Sanofi’s MS Drug Tripped Up by Toxicities, Unclear Benefit, Rejection Letter Reveals

January 6, 2026

3 min read

Tristan Manalac

FDA

FDA Went Against Adcomm Votes More, Held Fewer Meetings in 2025

January 6, 2026

3 min read

Heather McKenzie

FDA

Calls for Leadership Stability and Rare Disease Follow-Through at FDA in 2026

January 5, 2026

9 min read

Tristan Manalac

FEATURED STORIES

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Opinion

Addressing the Regulatory Reality of Replacing In Vivo Models in Drug Development

The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.

January 5, 2026

6 min read

Xiaoxia Li

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FDA

FDA Policy Tracker: 2025 Was a Year of Change

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.

December 22, 2025

13 min read

Heather McKenzie

Manufacturing

Big Pharma Pushes FDA To Decouple Inspections From Drug Approval Applications

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.

December 16, 2025

4 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