SUBSCRIBE
SUBSCRIBE
News

FDA

Multicolored orbeez balls scattered on a ASMR microphone. Autonomous Sensory Meridian Response. Relaxing sound concept. 3d illustration
Gene therapy
FDA approval of Regeneron’s hearing loss gene therapy breaks barriers
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
April 23, 2026
 · 
4 min read
 · 
Heather McKenzie
3D Yellow triangle warning sign symbol on yellow background. Emergency alert, and caution. Illustration with copy space
Manufacturing
FDA issues warning letter after GLP-1 manufacturer refuses inspectors access
April 22, 2026
 · 
2 min read
 · 
Nick Paul Taylor
Hypnotherapy session, subconscious research. Psychiatrist assistance. Hypnosis practice, altered state of mind, hypnosis treatment services concept. Header or footer banner template with copy space.
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
FDA
Drug pricing watchdog calls for increased transparency into FDA’s accelerated approval decisions
April 16, 2026
 · 
4 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
Success transformation and Transform to succeed or improving concept and leadership in business through innovation and evolution with paper origami changed for the better.
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
Business teamwork and partnership help to achieve team success, think together to solve business problem, business connection concept, businessmen working team building connect jigsaw puzzle bridge.
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
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Policy
Biopharma Update on the Novel Coronavirus: August 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
August 6, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves GSK’s Blenrep as Fourth-Line Multiple Myeloma Monotherapy Treatment
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.
August 6, 2020
 · 
3 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 5
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.
August 4, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
Gavreto is approved by FDA yet again.
FDA
FDA Approves MorphoSys and Incyte’s DLBCL Drug Monjuvi
Eight months after inking a collaboration deal, MorphoSys and Incyte won approval for Monjuvi for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
August 3, 2020
 · 
2 min read
 · 
Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: August 3
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August 3, 2020
 · 
3 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 31
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 31, 2020.
July 30, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: July 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 29, 2020.
July 29, 2020
 · 
5 min read
 · 
BioSpace Editorial Staff
Oxbryta gets greenlight for Pediatric SCD treatmen
FDA
FDA Greenlights Gilead/Kite’s Tecartus for Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) approved Kite Pharma’s Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory mantle cell lymphoma (MCL). Kite is a Gilead Science company.
July 24, 2020
 · 
3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: July 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 27, 2020.
July 24, 2020
 · 
2 min read
 · 
BioSpace Editorial Staff
FDA
AstraZeneca Wins FDA Approval for COPD Treatment
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
July 24, 2020
 · 
2 min read
 · 
Alex Keown
Load More