Givlaari (givosiran) has been approved by the FDA for the treatment of adult patients with the rare genetic disorder, acute hepatic porphyria.
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Food and Drug Administration (FDA)
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.
The pharmaceutical industry is set to face some major changes in the near future, to improve the quality of returned drugs and medications.
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
The FDA has announced Orphan Drug Designation for Imfinzi (durvalumab) to treat small cell lung cancer in combination with other therapies.
The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.
A pharmaceutical manufacturing site in New Jersey receives FDA warning letter for failing to thoroughly investigate quality problems and data integrity issues.
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
PR001 has received Fast Track Designation from the regulatory body for the treatment of Parkinson’s disease.
New guidance drafts have been announced by the FDA to improve patients understanding and keep information consistent.