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

Psychedelics

FDA awards priority vouchers to 3 undisclosed companies for investigational psychedelics

While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.

April 24, 2026

3 min read

Heather McKenzie

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Editorial

BioSpace elevates journalism as biopharma evolves in the Trump era

April 24, 2026

4 min read

Jef Akst

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Opinion

Opinion: Prasad’s FDA exit good for rare diseases but new CBER head must repair eroded trust

April 24, 2026

5 min read

Joshua R. Mansbach

Gene therapy

FDA approval of Regeneron’s hearing loss gene therapy breaks barriers

April 23, 2026

4 min read

Heather McKenzie

Manufacturing

FDA issues warning letter after GLP-1 manufacturer refuses inspectors access

April 22, 2026

2 min read

Nick Paul Taylor

Psychedelics

Trump’s psychedelics push a mixed blessing for neuropsychiatric companies, patients

April 22, 2026

8 min read

Heather McKenzie

Approvals

Merck steps up as ‘meaningful competitor’ to Gilead with HIV pill approval

April 22, 2026

1 min read

Tristan Manalac

FEATURED STORIES

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FDA

Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA

After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.

April 17, 2026

5 min read

Heather McKenzie

FDA

Deep dive: Checking in with the FDA

BioSpace looks back at 2025 and where the FDA is going in 2026.

April 15, 2026

2 min read

Heather McKenzie

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Regulatory

FDA flexibility isn’t absent but evolving regulations come with growing pains

The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.

April 13, 2026

5 min read

Heather McKenzie

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Drug Development

Biopharma Update on the Novel Coronavirus: April 10

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 10, 2020.

April 10, 2020

7 min read

BioSpace Editorial Staff

Drug Development

Biopharma Update on the Novel Coronavirus: April 9

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 9, 2020.

April 9, 2020

9 min read

BioSpace Editorial Staff

FDA

FDA Approves Pfizer’s Braftovi Plus Cetuximab for Colorectal Cancer with BRAF Mutations

“We are pleased by the FDA’s approval of Braftovi in combination with cetuximab, as we are committed to developing targeted medicines that can help people living with certain mutation-driven cancers,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.

April 9, 2020

2 min read

Mark Terry