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Approvals

FDA
Daiichi Sankyo Takes Two Products to FDA Advisory Panel; Gets One Yes, One No
The panel opposed approval of Daiichi Sankyo’s AML drug but supported approval for its TGCT treatment.
May 15, 2019
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3 min read
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Alex Keown
FDA
Regeneron’s Eylea Racks Up Another Approval, This Time for Diabetic Retinopathy
“With today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases,” stated George D. Yancopoulos, president and chief scientific officer at Regeneron.
May 14, 2019
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2 min read
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Mark Terry
FDA
Eli Lilly’s Cyramza Approved for HCC Patients, Boxed Warning Label Removed by FDA
The drug was approved as a second-line treatment for HCC patients who have an alpha-fetoprotein biomarker.
May 13, 2019
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2 min read
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Alex Keown
FDA
FDA Action Alert: Regeneron, Bristol-Myers Squibb and Incyte
May has been a fairly slow month for approvals by the U.S. Food and Drug Administration (FDA). There are currently only two scheduled for the rest of the month, with a third that has been withdrawn. Let’s take a look.
May 10, 2019
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3 min read
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Mark Terry
FDA
Neuronascent Announces FDA Clearance of IND Application for NNI-362 an Aging Therapy to Treat Alzheimer’s Disease
Neuronascent Inc. announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for its proprietary oral therapeutic, NNI-362, to proceed into Phase 1 clinical testing in a healthy aged population.
May 9, 2019
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6 min read
FDA
FDA Had Questions About Novartis’ Data Practices During Mayzent MS Approval
On March 27, the U.S. Food and Drug Administration (FDA) approved Novartis’ Mayzent (isiponimod) for adults with relapsing types of multiple sclerosis.
May 7, 2019
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3 min read
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Mark Terry
FDA
Catalyst Shares Plunge Following FDA Approval of Rival LEMS Drug
The Jacobus LEMS Drug was approved for pediatric patients. However, the approval was based on results from a study of adult patients, which means that doctors could opt to prescribe this medication for adult LEMS patients.
May 7, 2019
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2 min read
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Alex Keown
jejim/Shutterstock
FDA
Genentech’s Kadcyla Wins Second FDA Approval for HER2-Positive Breast Cancer
The FDA rapidly reviewed and approved the medication under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot program.
May 6, 2019
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2 min read
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Alex Keown
Roman Tiraspolsky/Shutterstock
FDA
Pfizer’s Tafamidis Approved in First for Rare Heart Disease
The approval is a first for the the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). The drug has a list price of $225,000.
May 6, 2019
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3 min read
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Alex Keown
FDA
Medtronic Receives FDA Approval for CareLink SmartSync Device Manager
Tablet-Based Device Manager Provides Portable and Secure Wireless Programming of Medtronic BlueSync(TM) Devices
May 2, 2019
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4 min read
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PRESS RELEASES
FDA
Ligand’s Partner Merck Receives FDA Approval for VAXNEUVANCE™ for the Prevention of Invasive Pneumococcal Disease in Adults Caused by 15 Serotypes
July 19, 2021
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5 min read
FDA
BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson’s Disease
July 19, 2021
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4 min read
FDA
Merck Announces U.S. FDA Approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes
July 16, 2021
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11 min read
FDA
FDA Grants First Full Approval for Treatment of Lymphoma in Dogs
July 15, 2021
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6 min read
FDA
Patient Impact Statement: FDA Approval Of Kerendia To Help Slow Kidney Disease And Failure Associated With Type 2 Diabetes
July 14, 2021
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4 min read
FDA
FDA Approves Accelerated Dosing in Non-Hodgkin’s Lymphoma/Leukemia Clinical Trial
July 13, 2021
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5 min read
FDA
FDA Approves Accelerated Dosing in Non-Hodgkin’s Lymphoma/Leukemia Clinical Trial
July 13, 2021
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5 min read
FDA
InVivo Therapeutics Announces FDA Acceptance of Preclinical Module in Support of Company’s Complete HDE Submission
July 13, 2021
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4 min read
FDA
Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
July 12, 2021
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4 min read
FDA
Prilenia: FDA Grants Orphan Drug Designation for pridopidine for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
July 12, 2021
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4 min read
FDA
Janssen Announces U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
July 12, 2021
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15 min read
FDA
FDA Approves Expanded Sterilization and Disinfectant Methods for the LUMINELLE® DTx System
July 12, 2021
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2 min read
FDA
Bayer’s KERENDIA® (finerenone) Receives U.S. FDA Approval for Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
July 9, 2021
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11 min read
FDA
U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer
July 9, 2021
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20 min read
FDA
Vect-Horus and RadioMedix Announce FDA Approval of Exploratory IND of Diagnostic 68 Ga-RMX-VH in Glioblastoma Multiforme
July 8, 2021
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3 min read
FDA
FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical TrialsADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia
July 8, 2021
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9 min read
FDA
Hyalex Orthopaedics receives FDA Breakthrough Device Designation for novel HYALEX® Cartilage System
July 7, 2021
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2 min read
FDA
Bold Therapeutics Receives FDA Clearance to Add U.S. Sites for Phase 1b / 2a Trial of BOLD-100 in the Treatment of Advanced GI Cancers
July 7, 2021
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4 min read
Drug Development
Sirnaomics Receives FDA Approval of IND for Phase 1 Clinical Trial of Systemic RNAi Therapeutic STP707 for Solid Tumor Treatment
July 6, 2021
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4 min read
FDA
Siemens Healthineers Announces FDA Clearance of MAGNETOM Free.Max 80 cm MR Scanner
July 6, 2021
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3 min read
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