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FDA Accepts BLA for Proposed Biosimilar Bevacizumab for Review americanpharmaceuticalreview
March 10, 2020
Mylan and Biocon announced the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin® (bevacizumab), for review under the 351(k) pathway.
F2G Receives Orphan Drug Designation for Olorofim americanpharmaceuticalreview
March 10, 2020
F2G announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead first-in-class candidate, olorofim (formerly F901318) for treatment of invasive aspergillosis ...
FDA approves Isturisa (osilodrostat) treatment for Cushing’s disease europeanpharmaceuticalreview
March 10, 2020
The FDA has approved Isturisa for Cushing’s disease treatment after it demonstrated significant efficacy in clinical trials.
FDA announces changes that will soon affect compounders europeanpharmaceuticalreview
March 10, 2020
A change to the law will soon be impacting compounding of certain products beginning on 23 March 2020 the US Food and Drug Administration (FDA) has announced.
US FDA concludes SMS Pharma’s inspection with zero observation expresspharma
March 10, 2020
The inspection was conducted at the company’s exclusive testing facility from March 2-26, 2020.
Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 PRNewswire
March 10, 2020
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products. These products are unapproved drugs that pose significant risks to patient health and vi
FDA Grants Orphan Drug Designation for Progressive SupraNuclear Palsy Treatment americanpharmaceuticalreview
March 09, 2020
Retrotope announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for its chemically-modified polyunsaturated fatty acid drug (RT001) ...
Valoctocogene Roxaparvovec BLA Accepted for Priority Review by FDA americanpharmaceuticalreview
March 09, 2020
BioMarin Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) to the FDA for its investigational AAV5 gene therapy ...
InPen Diabetes Management System Receives FDA Clearance for use with Fiasp® Insulin americanpharmaceuticalreview
March 09, 2020
Companion Medical announced clearance by the FDA for the use of Novo Nordisk's Fiasp® rapid-acting insulin.
FDA approves new treatment for adults with Cushing's disease worldpharmanews
March 09, 2020
The U.S. Food and Drug Administration approved Isturisa (osilodrostat) oral tablets for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease.

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