SUBSCRIBE
SUBSCRIBE

Food and Drug Administration (FDA)

NEWS
FDA
FDA Action Alert: Sanofi, Neurocrine, Correvio and United
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
April 17, 2020
 · 
3 min read
 · 
Mark Terry
Policy
FDA Prioritizing COVID-19, but Continuing Normal Routine as Much as Possible
The agency issued a statement saying that it will continue its activities, such as reviewing new drug applications and clinical trial, both COVID-19 and non-COVID-19, applications, “as we do everything possible to maintain continuity of operations in a very dynamic situation.”
April 17, 2020
 · 
2 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: April 17
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 17, 2020.
April 17, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
FDA
FDA Gives UroGen’s Jelmyto Expedited Approval for Urothelial Cancer
Jelmyto is the first and only non-surgical treatment for patients with this indication. Here’s everything you need to know about it.
April 16, 2020
 · 
2 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020.
April 16, 2020
 · 
8 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: April 15
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 15, 2020.
April 15, 2020
 · 
7 min read
 · 
BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: April 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 14, 2020.
April 14, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
FDA
FDA Approves Rutgers’ Saliva Test for COVID-19
The U.S. Food and Drug Administration granted emergency use authorization to Rutgers’ RUCDR Infinite Biologics for its test that uses saliva.
April 13, 2020
 · 
3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: April 13
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 13, 2020.
April 13, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Load More
JOBS
IN THE PRESS
Policy
May Health Announces Data From Feasibility Studies of its Novel Ovarian Rebalancing™ Treatment and Receives Approval From FDA for Pivotal Trial
June 26, 2023
 · 
5 min read
Policy
FDA Roundup: June 23, 2023
June 23, 2023
 · 
3 min read
FDA
FDA clears ImageBiopsy Labs’ latest AI-powered Software for a comprehensive Set of Automated Measurements on Long Leg Radiographs
June 23, 2023
 · 
2 min read
Drug Development
Molecure Files an Investigational New Drug (IND) application for lead clinical candidate OATD-01 with U.S. FDA ahead of a planned Phase 2 pulmonary sarcoidosis study
June 23, 2023
 · 
4 min read
Policy
Intercept Receives Complete Response Letter from FDA for Obeticholic Acid as a Treatment for Pre-Cirrhotic Fibrosis due to NASH
June 22, 2023
 · 
3 min read
FDA
Caristo Diagnostics Applauds FDA Approval of Colchicine as First Anti-Inflammatory Drug for Cardiovascular Disease
June 22, 2023
 · 
6 min read
FDA
New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy
June 22, 2023
 · 
5 min read
Policy
Haemonetics Receives FDA Clearance for Enhancements to NexSys PCS® Plasma Collection System
June 22, 2023
 · 
4 min read
FDA
FDA GRANTS FULL APPROVAL FOR BLINCYTO® (BLINATUMOMAB) TO TREAT MINIMAL RESIDUAL DISEASE-POSITIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA
June 21, 2023
 · 
18 min read
Drug Development
AceLink Therapeutics Receives FDA Clearance to Initiate a Phase 2 Study of AL1211 in Patients with Fabry Disease
June 21, 2023
 · 
5 min read
Load More