The drug makers co-developed the RSV shot for infants and toddlers called Beyfortus, which has already been approved for use in the European Union and United States.
Tag Archive for: regulatory approval
The drug, branded as Wainua, is approved for patients with polyneuropathy, or nerve damage caused by hereditary transthyretin amyloidosis (ATTR-PN), which affects an estimated 40,000 patients globally.
The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.
Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma. Tuesday’s approval comes nearly two years after an initial rejection by the regulator.
The addictive potential of the painkillers has fueled an opioid epidemic that has caused more than half a million overdose deaths in the United States over a period spanning more than two decades.
In the next two weeks, the agency will release regulatory decisions on investigational treatments for a rare hereditary disorder, non-small cell lung cancer and more.
The drug, branded as Welireg, is used to treat patients with renal cell carcinoma who have received prior treatment.
In its most basic form, market access means ensuring patients can physically get a product. Sounds simple, right?
