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The US Food and Drug Administration (FDA) has approved Tzield, the first drug that can help delay the onset of stage 3 type 1 diabetes in patients over eight years old with stage 2 type 1 diabetes.
A bispecific antibody for multiple myeloma gets Breakthrough Therapy Designation based on 61 percent overall response trial data.
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera.
Givlaari (givosiran) has been approved by the FDA for the treatment of adult patients with the rare genetic disorder, acute hepatic porphyria.
President Trump has announced his intent to nominate Stephen Hahn as Commissioner of Food and Drugs at the Department of Health and Human Services.
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 approved RUXIENCE (rituximab-pvvr), a biosimilar to Rituxan® (rituximab), for treatment of non-Hogkin’s lymphoma and other conditions.
The FDA has announced that it has granted approval to the first nine generic drug applications for Pfizer’s Lyrica treatment.
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.
Altaire Pharmaceuticals has announced a recall of 31 products due to a lack of sterility assurance from their manufacturing facility.
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The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.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.
