SUBSCRIBE
SUBSCRIBE

Approvals

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Adamas Wins FDA OK for the First and Only Drug for Parkinson’s Dyskinesia Drug
August 25, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Heads Up Tesaro: AstraZeneca PLC, Merck & Co.'s Ovarian Cancer Drug Just Got Expanded Use From the FDA
August 18, 2017
 · 
3 min read
For Sale: Pfizer's $3.4 Billion Consumer Healthcare Business
FDA
FDA Green Lights Pfizer Drug for Rare, Fast-Killing Type of Leukemia
August 18, 2017
 · 
2 min read
FDA
Approval of Medical Device Changes Often Based On Low-Quality Research, UCSF and Yale University School Of Medicine Study
August 17, 2017
 · 
1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
This is What Happens When the FDA Approves Cancer Drugs Too Quickly
August 17, 2017
 · 
3 min read
AbbVie Leaps Into the Land of Oncolytics With New Turnstone Biologics Tie-Up
FDA
AbbVie Wins FDA Approval for the First-Ever Drug to Treat All Forms of Hep C
August 4, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Advisory Panel Votes Against Approval Of Johnson & Johnson’s Sirukumab
August 3, 2017
 · 
2 min read
FDA
Blood Markers Of Chronic Fatigue Syndrome Could Pave The Way To A Diagnostic Test, Stanford Reveals
August 2, 2017
 · 
1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Agios, Celgene Win Early FDA Approval for New Cancer Drug
August 1, 2017
 · 
2 min read
Pharma Giant AstraZeneca PLC Scores Another FDA Breakthrough
FDA
Pharma Giant AstraZeneca PLC Scores Another FDA Breakthrough
August 1, 2017
 · 
2 min read
Load More
PRESS RELEASES
FDA
Embody, Inc. Announces FDA 510(k) Clearance of TAPESTRY® Biointegrative Implant for Tendon and Ligament Repair
October 22, 2020
 · 
2 min read
FDA
Reven Pharmaceuticals Wins FDA Approval of Its IND Application for Treatment of COVID-19 With Rejuveinix (RJX)
October 22, 2020
 · 
7 min read
FDA
Nevakar Announces FDA Approval for Ephedrine Sulfate Injection as Ready-to-Use Vials
October 22, 2020
 · 
1 min read
FDA
Aidoc granted AI industry-first FDA clearance for triage of incidental pulmonary embolism
October 21, 2020
 · 
2 min read
FDA
Ezra Receives FDA Clearance For Prostate Cancer Artificial Intelligence
October 20, 2020
 · 
3 min read
FDA
Spectrum Solutions Secures Emergency Use Authorization (EUA) for its SDNA-1000 Saliva Collection Device, Expanding Access and COVID-19 Testing Options
October 20, 2020
 · 
3 min read
FDA
Octapharma announces FDA approval of updated NUWIQ® Prescribing Information to include immunogenicity data in previously untreated patients
October 19, 2020
 · 
3 min read
FDA
Neurelis Announces FDA Approval Of Extended Expiration Dating For VALTOCO® (Diazepam Nasal Spray)
October 19, 2020
 · 
6 min read
FDA
OSSIO Awarded FDA 510(k) Clearance for OSSIOfiber® Compression Screw Portfolio
October 19, 2020
 · 
5 min read
FDA
FDA Approves New Container System for Peritoneal Dialysis Solutions
October 19, 2020
 · 
5 min read
Drug Development
Edesa Biotech Receives Approval to Initiate COVID-19 Study in the U.S.
October 19, 2020
 · 
5 min read
FDA
Genentech Announces Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia
October 16, 2020
 · 
13 min read
FDA
VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML)
October 16, 2020
 · 
18 min read
FDA
Bracco Diagnostics Inc. Introduces New CardioGen-82® (Rubidium Rb 82 Generator) Infusion System
October 16, 2020
 · 
5 min read
FDA
Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Zonisamide Oral Suspension- Application Assigned a PDUFA Date of May 29, 2021
October 15, 2020
 · 
2 min read
FDA
Seattle Gummy Company Secures The First (IND) Gummy Drug Approval From FDA
October 15, 2020
 · 
2 min read
FDA
Precigen’s UltraPorator™ Receives FDA Clearance for Manufacturing UltraCAR-T® Cells in Clinical Trials
October 15, 2020
 · 
6 min read
FDA
Armata Pharmaceuticals Announces Clearance of Investigational New Drug (IND) Application to Initiate Phase 1b/2a Clinical Trial of Lead Candidate AP-PA02 in Pseudomonas aeruginosa Infections
October 15, 2020
 · 
5 min read
FDA
FDA Approves First Treatment for Ebola Virus
October 14, 2020
 · 
4 min read
FDA
RedHill Biopharma Announces FDA Orphan Drug Designation for RHB-204 for the Treatment of NTM Infections
October 14, 2020
 · 
10 min read
Load More