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

Regulatory

FDA Carves Out Manufacturing Exemptions for CGTs To Accelerate Development

FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.

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

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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

Opinion

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

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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Regulatory

FDA’s ‘Conundrum’: What To Do With Approved Drugs That Fail Pivotal or Confirmatory Trials

With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”

December 15, 2025

7 min read

Heather McKenzie

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Inmazeb is the world's first treatment for Ebola.

FDA

Regeneron’s Inmazeb Becomes First Ebola Treatment Approved by FDA

Regeneron announced that the U.S. Food and Drug Administration approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children.

October 15, 2020

3 min read

Mark Terry

Policy

Biopharma Update on the Novel Coronavirus: October 13

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 13, 2020.

October 13, 2020

4 min read

BioSpace Editorial Staff

Policy

Biopharma Update on the Novel Coronavirus: October 6

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 6, 2020.

October 6, 2020

4 min read

BioSpace Editorial Staff

FDA

LabCorp Receives EUA from FDA for New High-Speed COVID-19 Test

The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.

October 2, 2020

3 min read

Brandon May

FDA

Judge Sides with FDA, Jacobus Pharma in Fight Over LEMS Treatment Approval

Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.

September 30, 2020

2 min read

Alex Keown

FDA

FDA Gives GSK’s Nucala the Greenlight for Hypereosinophilic Syndrome

The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.

September 28, 2020

2 min read

Brandon May

FDA

FDA Grants Mereo’s Setrusumab Rare Pediatric Disease Designation

Under that designation, Mereo may qualify for a voucher that can be used for a priority review of a subsequent marketing application for a different product than Setrusumab.

September 24, 2020

2 min read

Mark Terry