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Approvals

Foundation Medicine Wins Approval From the FDA an
FDA
Foundation Medicine Wins Approval From the FDA and Medicare for First-of-Its-Kind Cancer Test
Foundation Medicine’s sequencing diagnostics test for solid tumors that can detect cancer-causing mutations in 324 genes was approved by the FDA Thursday.
November 30, 2017
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2 min read
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Alex Keown
FDA
GlaxoSmithKline’s ViiV Healthcare Wins First FDA OK for Two-Drug HIV Regimen
HIV patients have a new maintenance drug in their arsenal of medication.
November 21, 2017
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2 min read
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Alex Keown
FDA
The FDA Cleared 19 Spine Devices in October Alone
A look at the 19 spine-related medical devices the FDA cleared in October.
November 21, 2017
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1 min read
FDA
Pfizer Wins Expanded FDA Nod for Cancer Drug Sutent
The FDA approved a label expansion for Pfizer’s cancer drug Sutent to include the adjuvant treatment of adult patients at high risk of RCC following the surgical removal of the cancerous kidney.
November 16, 2017
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2 min read
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Alex Keown
FDA
On a Roll: FDA OKs Genentech’s Gazyva for Untreated Follicular Lymphoma
Genentech scored two approvals from the FDA this week.
November 16, 2017
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2 min read
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Alex Keown
FDA
FDA Approves Genentech’s Hemlibra, the First Drug in 20 Years for Hemophilia A With Inhibitors
The drug will be used to prevent or reduce the frequency of bleeding episodes in certain patients.
November 16, 2017
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3 min read
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Alex Keown
FDA
How Sweet It Is: Dynavax Finally Wins FDA OK for Hep B Vaccine Heplisav
The FDA approved Dynavax’s Heplisav-B, it’s first new hepatitis B vaccine in the U.S. in more than 25 years.
November 9, 2017
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2 min read
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Mark Terry
Business
AiCuris to Pocket $122M as Merck Wins FDA Approval for New CMV Infection Drug
CMV is a common and potentially serious viral infection in allogeneic HSCT recipients.
November 9, 2017
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2 min read
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Mark Terry
FDA
FDA Approves Genentech’s Zelboraf, the First-Ever Drug to Treat Specific Rare Blood Disease
People diagnosed with the rare blood disorder known as Erdheim-Chester disease have a new treatment option.
November 6, 2017
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2 min read
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Alex Keown
FDA
Eye Tech Care’s Ultrasound Glaucoma Treatment Approved for China Use
EyeOP1 is an high-intensity focused ultrasound device that is the first non-invasive treatment for glaucoma in China.
November 3, 2017
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1 min read
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PRESS RELEASES
FDA
Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19
November 12, 2020
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3 min read
FDA
Surface Oncology Announces FDA Fast Track Designation Granted by U.S. Food and Drug Administration for SRF388 to Treat Liver Cancer
November 11, 2020
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5 min read
FDA
Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL® Cell Therapy) to Treat Organ Vascular Niche Injuries for the Prevention of Severe Toxicities in Lymphoma Patients
November 11, 2020
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5 min read
FDA
Sebela Pharmaceuticals Receives FDA Approval for SUTAB® Tablets for Colonoscopy Preparation
November 10, 2020
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9 min read
FDA
Immune-Onc Therapeutics Announces Orphan Drug Designation of IO-202 (Anti-LILRB4) for Treatment of AML and Poster Presentation at ASH 2020
November 10, 2020
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6 min read
FDA
NightWare Receives FDA Marketing Permission for First and Only Medical Device to Reduce Sleep Disturbances Related to PTSD-Associated Nightmares in Adults
November 10, 2020
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5 min read
FDA
Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT™ (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients
November 9, 2020
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3 min read
FDA
Foundation Medicine Expands Indication for FoundationOne®Liquid CDx to be used as a Companion Diagnostic for LYNPARZA®
November 9, 2020
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6 min read
FDA
U.S. FDA Accepts Ortho’s Emergency Use Notification for VITROS® SARS-CoV-2 Antigen Test--Capable of Accurate Mass-Scale Testing
November 4, 2020
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5 min read
FDA
LogicBio Therapeutics Receives FDA Fast Track Designation for LB-001 for the Treatment of Methylmalonic Acidemia (MMA)
November 4, 2020
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4 min read
FDA
FDA Approves Updated Label for Endari®
November 3, 2020
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3 min read
FDA
Chiesi USA, Inc. announces FDA approval of Bronchitol® (mannitol) inhalation powder Bronchitol® indicated as add-on maintenance therapy to improve pulmonary function in adult patients with cystic fibrosis (CF)
November 2, 2020
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6 min read
FDA
Boston Scientific Receives FDA Approval for the Ranger™ Drug-Coated Balloon
November 2, 2020
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7 min read
FDA
TaiGen Announces FDA Approval of IND for Its Flu Antiviral TG-1000
November 1, 2020
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2 min read
Drug Development
OliX Pharmaceuticals Announces FDA Clearance of the IND to Evaluate the Efficacy of OLX10010 in Phase 2a Clinical Trial for Hypertrophic Scars
October 30, 2020
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2 min read
FDA
Nexus Pharmaceuticals Receives FDA Approval for Succinylcholine Chloride Injection, USP
October 29, 2020
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1 min read
FDA
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
October 29, 2020
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3 min read
FDA
FDA Grants Rafael Pharmaceuticals Orphan Drug Designation for CPI-613® (devimistat) for Treatment of Soft Tissue Sarcoma Company to launch clinical trial in clear cell sarcoma, a subtype of soft tissue sarcoma, in the coming months
October 29, 2020
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4 min read
Drug Development
OncoSec Announces FDA Clearance of IND Application for Initiation of Phase 1 Clinical Trial of its CORVax12 Vaccine Candidate for COVID-19
October 29, 2020
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7 min read
FDA
Genprex Receives Conditional FDA Acceptance of Proprietary Name REQORSA™ for Lead Drug Candidate for Treatment of Non-Small Cell Lung Cancer
October 29, 2020
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5 min read
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