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

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Approvals

Sentynl, Fortress Bounce Back With FDA Approval for Rare Pediatric Disease

The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.

January 13, 2026

2 min read

Tristan Manalac

FDA signage at its headquarters in Maryland

Manufacturing

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

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

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

FEATURED STORIES

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FDA

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

After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.

January 5, 2026

9 min read

Tristan Manalac

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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

Digital compass. Business strategic explorer, Vision crisis, Mission path, Agency creative, Digital strategy, Market decision, Achievement strategy, Financial stock, Company vision concepts

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

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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