SUBSCRIBE
SUBSCRIBE

Approvals

Gilead Suffers Another R&D Setback as Myelofibrosis Drug Flops in Phase III, Gives Credence to Acquisition Urgency
FDA
FDA Green Lights Gilead’s Vosevi, With a Black Box Warning Attached
July 19, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Puma Biotech Surges After the FDA Officially Approves Breast Cancer Drug
July 18, 2017
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Gives Nod to Johnson & Johnson’s Potential Blockbuster Psoriasis Med
July 14, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Panel Unanimously Endorses Novartis AG’s CAR-T Leukemia Drug
July 13, 2017
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3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Little-Known Emmaus Just Won Approval for First New Sickle Cell Drug in 20 Years
July 10, 2017
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2 min read
FDA
Here’s What The Latest Thermo Fisher Scientific Really Means And Why It’s So Important
June 28, 2017
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1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Bay Area’s Portola Rockets as the FDA Approves First and Only Anticoagulant for Hospitals
June 26, 2017
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2 min read
FDA
The FDA Has Never Approved A Drug Like This In Its 111-Year History
June 26, 2017
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1 min read
FDA
A Peek At Adamis Ahead Of FDA Approval
June 16, 2017
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1 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Bay Area’s Coherus Craters After the FDA Spurns Its Biosimilar for Amgen’s Neulasta
June 12, 2017
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3 min read
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PRESS RELEASES
FDA
Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy
October 14, 2020
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11 min read
FDA
Orca Bio Receives Regenerative Medicine Advanced Therapy (RMAT) Designation for Orca-T — FDA grants RMAT and Orphan Drug Designations (ODD) to Orca-T for treating patients eligible for allogeneic hematopoietic stem cell transplant —
October 14, 2020
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2 min read
FDA
CrossBay Medical Receives FDA Clearance for CrossGlide ETS Plus
October 13, 2020
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2 min read
FDA
miR Scientific announces FDA Breakthrough Device Designation for its Prostate Cancer Liquid Biopsy Test
October 13, 2020
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2 min read
FDA
Now Over-the-Counter: FDA Clears CEFALY® DUAL Migraine Treatment for Use Without a Prescription
October 13, 2020
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2 min read
FDA
Cerus Corporation Announces Five-Year FDA Contract for the Development of Next Generation Pathogen Reduction Technology to Treat Whole Blood
October 13, 2020
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4 min read
FDA
Nuvation Bio Announces FDA Acceptance of Investigational New Drug (IND) Application for NUV-422 for Treatment of Patients with High-grade Gliomas
October 13, 2020
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3 min read
FDA
FDA Clearance Granted to WishBone Medical’s Pediatric External Fixation SystemSmart Correction® External Fixator and proprietary software to offer greater efficiency and accuracy for surgeons treating children.
October 13, 2020
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3 min read
FDA
Foldax Named Cardiovascular Device Company of the Year by MedTech Outlook
October 13, 2020
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2 min read
FDA
FH Ortho Receives FDA Clearance for Telegraph Evolution Humeral Nail System
October 13, 2020
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1 min read
FDA
Abbott Receives FDA Emergency Use Authorization for its COVID-19 IgM Antibody Blood Test
October 12, 2020
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3 min read
FDA
Alexion Receives FDA Approval for New Advanced Formulation of ULTOMIRIS® (ravulizumab-cwvz) with Significantly Reduced Infusion Time
October 12, 2020
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20 min read
FDA
GE Healthcare Receives FDA Clearance for Vivid Ultra Edition, AI-Powered Cardiovascular Ultrasound System Designed to Shorten Diagnostic Exam Time and Improve Measurement Consistency
October 12, 2020
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3 min read
FDA
Immunomedics Announces FDA Orphan Drug Designation of Trodelvy™ for Adult and Pediatric Glioblastoma
October 12, 2020
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8 min read
FDA
CartiHeal Receives FDA “Breakthrough Device Designation” for the novel Agili-C Implant
October 12, 2020
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2 min read
FDA
Ascentage Pharma’s Apoptosis-Targeting Drug Candidates Granted Two More Orphan Drug Designations by the US FDA
October 8, 2020
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5 min read
FDA
XORTX Receives Positive Feedback from FDA on COVID-19 Related Acute Kidney Injury● Clear Development Path Forward for XRx-101 ●
October 8, 2020
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5 min read
FDA
Curtana Pharmaceuticals’ CT-179 Receives Rare Pediatric Disease Designation from the U.S. FDA for the Treatment of Medulloblastoma
October 7, 2020
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3 min read
FDA
Y-mAbs’ Nivatrotamab for the Treatment of Patients with Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA
October 7, 2020
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5 min read
FDA
BioMarin, Pioneer in Rare Disease Treatments for Phenylketonuria (PKU), Receives FDA Approval of Label Expansion to Allow Maximum Dose of 60 mg for Palynziq® (pegvaliase-pqpz) Injection for Treatment of Adults with PKU
October 7, 2020
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17 min read
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