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

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Opinion

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

The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.

April 24, 2026

5 min read

Joshua R. Mansbach

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Gene therapy

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

April 23, 2026

4 min read

Heather McKenzie

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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

Policy

FDA Policy Tracker 2026: Psychedelics get a boost

April 20, 2026

10 min read

BioSpace Editorial Staff

FDA

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

April 17, 2026

5 min read

Heather McKenzie

FEATURED STORIES

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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FDA

FDA’s CRL transparency policy is boosting biopharma accountability

Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.

April 13, 2026

5 min read

Nick Paul Taylor

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THE LATEST

Policy

Biopharma Update on the Novel Coronavirus: July 6

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

July 6, 2020

2 min read

BioSpace Editorial Staff

Policy

Biopharma Update on the Novel Coronavirus: July 3

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 3, 2020.

July 2, 2020

1 min read

BioSpace Editorial Staff

FDA gave green signal to Beigene's Brukinsa after

FDA

FDA Gives Pfizer and Merck KGaA’s Bavencio a Thumbs-Up for Urothelial Cancer

Bavencio is an anti-PD-L1 checkpoint inhibitor co-developed by Merck KGaA, Darmstadt, German and Pfizer via EMD Serono, a business unit of the two companies.

July 1, 2020

3 min read

Mark Terry

Drug Development

Biopharma Update on the Novel Coronavirus: July 1

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 1, 2020.

June 30, 2020

3 min read

BioSpace Editorial Staff

FDA

Merck’s Keytruda Approved for First-Line Treatment of Colorectal Cancer

The anti-PD-1 therapy was approved by the U.S. Food and Drug Administration alone for first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

June 30, 2020

3 min read

Mark Terry

Policy

Biopharma Update on the Novel Coronavirus: June 29

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 29, 2020.

June 29, 2020

2 min read

BioSpace Editorial Staff

FDA

Allergan/AbbVie’s Macular Degeneration Drug Abicipar Pegol Rejected by FDA

The U.S. Food and Drug Administration issued a Complete Response Letter, a rejection, of Allergan’s Biologics License Application for Abicipar pegol for neovascular age-related macular degeneration.

June 26, 2020

3 min read

Mark Terry

FDA

Zogenix Wins Approval for Dravet Syndrome Treatment Fintepla

Shares of Zogenix were up more than 16% in premarket trading following the regulatory approval of the epilepsy drug Fintepla for the treatment of seizures associated with Dravet syndrome, a rare form of epilepsy, in patients ages two and above.

June 26, 2020

2 min read

Alex Keown