The US Food and Drug Administration (FDA) approved a new oral antibiotic to treat uncomplicated urinary tract infections (uUTIs). Orlynvah (sulopenem etzadroxil and probenecid) is a broad-spectrum ...
Four years after getting the first drug approved by the FDA to treat rare disease hereditary ATTR amyloidosis, Alnylam has got the go-ahead for a second – Amvuttra – which has a simpler ...
The FDA approval of HYMPAVZI was supported by the Phase III BASIS clinical trial. Credit: Andrey_Popov/Shutterstock. Pfizer has announced the approval of HYMPAVZI ...
The FDA has approved a new flu vaccine nasal spray for at-home use. While this self-administered version won't be available for this year's flu season, interest in nasal spray products is growing.
The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday. The regulator approved Vyalev, also known as ...
Common side effects include decreased neutrophils, increased glucose, fatigue, and stomatitis, affecting over 20% of patients. The Food and Drug Administration (FDA) has approved Itovebi (inavolisib) ...
rejecting Jazz Pharmaceuticals’ attempt to overturn the FDA approval. Jazz argued that the approval infringed on the seven-year market exclusivity granted to its narcolepsy drug, Xywav (sodium oxybate ...
Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at ...
After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. The FDA on Friday gave Vyloy (zolbetuximab) the thumbs-up ...
The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson's disease (PD). The chronic ...