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Approvals

FDA
Incyte’s Jakafi Snags FDA Approval for Treatment of Steroid-Refractory Acute GVHD
The approval of Jakafi marks the first approved treatment for this indication in the United States.
May 28, 2019
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2 min read
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Alex Keown
lucarista/Shutterstock
FDA
Novartis’ SMA Gene Therapy Treatment Approved by FDA, Priced at $2.125 Million
The price of the one-and-done gene therapy treatment is about half of what was initially projected by Novartis.
May 24, 2019
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4 min read
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Alex Keown
FDA
Novocure Wins FDA Approval for First Mesothelioma Treatment in 15 Years
Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.
May 24, 2019
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2 min read
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Alex Keown
FDA
Australia’s Mayne Pharma Receives FDA Nod for Adolescent Plaque Psoriasis Treatment
Sorilux was approved for the treatment of patients age 12 and up.
May 22, 2019
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2 min read
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Alex Keown
StockStudio/Compressed
FDA
FDA Approves Pfizer’s Treatment for Fatal, Rare Heart Disease
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.
May 21, 2019
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3 min read
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Alex Keown
FDA
Takeda Wins FDA Approval for Pediatric Use of Short Bowel Syndrome Treatment
The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.
May 20, 2019
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2 min read
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Alex Keown
FDA
UCB Wins FDA Approval for Epilepsy Treatment Acquired in $370 Million Deal
NAYZILAM was approved to treat frequent seizure cluster episodes in epilepsy patients.
May 20, 2019
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2 min read
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Alex Keown
StockStudio/Compressed
FDA
FDA Approves First VTE Treatment for Pediatric Patients
Pfizer’s Fragmin was approved to reduce the recurrence of VTE in patients one month of age or older.
May 17, 2019
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2 min read
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Alex Keown
FDA
FDA Approves Combination Treatment for CLL and SLL
The combination of Venclexta and Gazyva was rapidly approved by the FDA under a pilot program.
May 16, 2019
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2 min read
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Alex Keown
FDA
Merck KGaA and Pfizer Snag FDA Approval for RCC Drug
The approval marks the first time the FDA has approved a checkpoint inhibitor for the treatment of advanced renal cell cancer.
May 15, 2019
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2 min read
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Alex Keown
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PRESS RELEASES
FDA
FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
July 28, 2021
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5 min read
Drug Development
Inhibikase Therapeutics Receives FDA Clearance To Begin Evaluation of IkT-148009 in Parkinson’s Patients
July 26, 2021
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6 min read
FDA
DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients
July 23, 2021
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8 min read
FDA
BYDUREON BCise (exenatide extended-release) Approved in the US for the Treatment of Type 2 Diabetes in Pediatric Patients Ages 10 Years and Older
July 23, 2021
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9 min read
FDA
FDA Approves KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma
July 22, 2021
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67 min read
FDA
FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris® System
July 21, 2021
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3 min read
FDA
Philips receives FDA Breakthrough Device Designation for laser-assisted IVC filter removal device
July 21, 2021
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4 min read
FDA
Omniscient Neurotechnology Launches Quicktome™ Brain Mapping Platform for Neurosurgery After Regulatory Clearance in United States, Canada and Australia
July 21, 2021
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5 min read
Drug Development
Viracta Therapeutics Announces FDA Clearance of IND Application for Phase 1b/2 Trial in Epstein-Barr Virus-Positive (EBV+) Solid Tumors
July 21, 2021
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6 min read
FDA
Organicell Announces FDA Approval Of IND Application For The Use Of Zofin™ In COVID-19 Long Haulers
July 21, 2021
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5 min read
FDA
Inozyme Pharma Receives Orphan Drug Designation for INZ-701 from the European Medicines Agency for the Treatment of ABCC6 Deficiency
July 21, 2021
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6 min read
FDA
U.S. Food and Drug Administration Expands Indication for PROGRAF® for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients
July 20, 2021
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13 min read
FDA
MULTIMEDIA UPDATE - Albireo Announces FDA Approval of Bylvay™ (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
July 20, 2021
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14 min read
FDA
Albireo Announces FDA Approval of Bylvay™ (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
July 20, 2021
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13 min read
FDA
FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis
July 20, 2021
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6 min read
FDA
Flatiron Health Real-World Data Support FDA Approval of New Dosing Regimen for ERBITUX® (cetuximab)
July 20, 2021
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3 min read
FDA
Aldeyra Therapeutics Receives Orphan Drug Designation from the U.S. Food and Drug Administration for ADX-2191 to Treat Primary Vitreoretinal Lymphoma
July 20, 2021
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7 min read
Drug Development
G1 Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for COSELA™ (Trilaciclib) in Combination with Chemotherapy for the Treatment of Locally Advanced or Metastatic Triple Negative Breast Cancer
July 19, 2021
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5 min read
FDA
Endologix LLC Receives FDA Breakthrough Device Designation for ChEVAS™ System
July 19, 2021
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5 min read
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
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