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

Sanofi Scores FDA Nod for Rare Anemia Drug

The FDA’s decision is based on favorable results from Sanofi’s Phase III CARDINAL trial, a 26-week open label, single arm study on 24 CAD patients.

February 7, 2022

2 min read

Vanessa Doctor, RN

Liu Guanguan/China News Service via Getty

Drug Development

Future of Key Asset in Question as Gilead Reveals More Holds

February 3, 2022

2 min read

Alex Keown

Drug Development

Milestone Cabenuva Approval Cuts Antiretroviral Dosing by Half

February 1, 2022

2 min read

Alex Keown

FDA

With EUA, Novavax Looks to Add Protein-Based Vaccine to U.S. Arsenal

February 1, 2022

3 min read

Mark Terry

Drug Development

In Step Forward, FDA Approves First Bispecific Antibody for AMD and DME

January 31, 2022

2 min read

Vanessa Doctor, RN

Drug Development

Immunocore Scores Milestone Approval for Rare Melanoma Drug

January 26, 2022

3 min read

Mark Terry

FDA

Omicron Too Much for Lilly, Regeneron Treatments as FDA Curbs Use

January 25, 2022

2 min read

Vanessa Doctor, RN

FEATURED STORIES

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Regulatory

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.

November 17, 2025

6 min read

Heather McKenzie

Opinion

How the FDA Is Accelerating Cell and Gene Therapy’s Next Chapter

Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.

November 14, 2025

6 min read

Anshul Mangal

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Editorial

FDA’s Bad Rap: Pazdur Steps Up as Agency Continues To Take on Water

Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.

November 13, 2025

8 min read

Jef Akst

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THE LATEST

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