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Approvals

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Sarepta Gets No Love From the FDA’s New Drugs Director
October 20, 2016
 · 
3 min read
FDA
Genentech’s Tecentriq Wins Second Approval of the Year, This Time for Lung Cancer
October 19, 2016
 · 
11 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
PTC Therapeutics Tanks After the FDA Denies DMD Drug Translarna Again
October 17, 2016
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
October 10, 2016
 · 
2 min read
Genentech Grows on Promise of 70+ Drug Approvals
Drug Development
Genentech’s Lung Cancer Drug Alecensa Gets 2nd FDA Breakthrough Status
October 4, 2016
 · 
2 min read
Why This Tiny Biotech is Giving Cash to Amgen Researchers
FDA
FDA Clears Amgen Copy of AbbVie’s Blockbuster Humira
September 26, 2016
 · 
3 min read
Did FDA Just Destroy Its Credibility?
FDA
BioPharm Executive: Did the FDA Just Destroy Its Credibility?
September 23, 2016
 · 
5 min read
FDA
Approving A Muscular Dystrophy Drug Exposes A Civil War At The FDA
September 20, 2016
 · 
1 min read
This Is Why Woodcock OKed Sarepta's DMD Drug
FDA
Meet the Powerful Woman Behind the Scenes of Sarepta’s DMD Drug Approval
September 20, 2016
 · 
4 min read
M&A Speculation Begins as Sarepta CEO Puts In His Notice
FDA
Victory at Last! Sarepta Stock Doubles as the FDA Finally Approves DMD Drug
September 19, 2016
 · 
3 min read
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PRESS RELEASES
FDA
U.S. FDA Approves Athena Bioscience’s New Drug Application (NDA) for QDOLO™ (tramadol hydrochloride) Oral Solution
September 8, 2020
 · 
8 min read
FDA
Kleo Pharmaceuticals Announces Orphan Drug Designation for KP1237 in Multiple MyelomaCD38-Targeting Molecule To be Evaluated in Multiple Patient Populations
September 8, 2020
 · 
3 min read
FDA
Caribou Biosciences Announces FDA Clearance of its IND for CB-010, an Off-the-shelf Allogeneic Anti-CD19 CAR-T Cell Therapy
September 8, 2020
 · 
2 min read
FDA
FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer
September 8, 2020
 · 
4 min read
FDA
Genentech Announces FDA Approval of Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
September 4, 2020
 · 
9 min read
FDA
Project ALS Granted FDA Orphan Drug Designation for Prosetin for the Treatment of Amyotrophic Lateral Sclerosis
September 4, 2020
 · 
1 min read
FDA
Ascendis Pharma A/S Announces U.S. Food and Drug Administration (FDA) Accepts Biologics License Application (BLA) for TransCon™ hGH for Pediatric Growth Hormone Deficiency (GHD)
September 4, 2020
 · 
6 min read
FDA
Alphamab Oncology announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to KN046 for the treatment of thymic epithelial tumor
September 3, 2020
 · 
6 min read
FDA
Fujifilm Sonosite Receives FDA COVID-19 510(k) Clearance for Comprehensive Point-of-Care Ultrasound Portfolio
September 3, 2020
 · 
3 min read
FDA
FDA Review of Approved Drug, Ubrogepant, Included DILIsym Simulations
September 2, 2020
 · 
5 min read
FDA
Adial Pharmaceuticals to Present at The LD Micro 500 Virtual Conference on September 2nd
September 1, 2020
 · 
2 min read
FDA
Medtronic Announces FDA Approval for MiniMed™ 770G Insulin Pump System with Smartphone Connectivity for People with Type 1 Diabetes
September 1, 2020
 · 
5 min read
FDA
Plus Therapeutics, Inc. receives FDA Orphan Drug Designation for its Novel Glioblastoma TreatmentCompany Initiates Sixth Dosing Cohort in ReSPECT Trial
September 1, 2020
 · 
4 min read
FDA
NKMax America Receives FDA Clearance to Amend its Current Phase I Monotherapy Trial to Include an Additional New Cohort of SNK01 + Checkpoint Inhibitor in Refractory Solid Tumors
August 31, 2020
 · 
1 min read
FDA
Masimo O3® Regional Oximetry Receives FDA Clearance for Somatic Applications and Measurement of Relative Changes in Cerebral Hemoglobin
August 31, 2020
 · 
10 min read
FDA
FDA Approves XARACOLL® (bupivacaine HCl) Implant, a Non-opioid, Drug-device Treatment Option for Acute Postsurgical Pain Relief for up to 24 Hours Following Open Inguinal Hernia Repair in Adults
August 31, 2020
 · 
5 min read
FDA
Baxter Announces U.S. FDA De Novo Authorization for Theranova Dialyzers Enabling HDx Therapy
August 31, 2020
 · 
7 min read
Drug Development
FDA Clears Can-Fite to Commence Phase II COVID-19 Study
August 31, 2020
 · 
6 min read
FDA
U.S. FDA Grants 510(k) Clearance for Spectral’s DIMI
August 31, 2020
 · 
7 min read
FDA
Gilead’s Investigational Antiviral Veklury® (Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19
August 28, 2020
 · 
8 min read
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