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Telix Files TLX250-CDx (Zircaix®) BLA for Kidney Cancer Imaging PRNewswire
December 30, 2024
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical technologies.
Polpharma Biologics Announces FDA Approval of Tyruko® - First And Only Approved Biosimilar to Tysabri®* for Relapsing Forms of Multiple Sclerosis PharmaSources
August 28, 2023
On August 25, 2023,Polpharma Biologics announced today that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko®.
FDA Inspections of Outsourcing Facilities FDA
March 31, 2022
Provide an overview of the inspection process for compounding outsourcing facilities.
Immunogenicity Information in Labeling FDA
March 25, 2022
This webinar has been approved for 1.5 contact hours of continuing education for pharmacists, physicians, and nurses. Please see detailed announcement for additional information.
FDA Approves First Generic of Symbicort to Treat Asthma and COPD FDA
March 17, 2022
Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions...
FDA Approves Treatment for Wider Range of Patients with Heart Failure FDA
February 25, 2022
The U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA FDA
February 18, 2022
In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s recommendations...
Office of Generic Drugs 2021 Annual Report FDA
February 16, 2022
Welcome to the seventh Annual Report from the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
Pfizer and BioNTech to extend rolling submission for Covid-19 vaccine Pharmaceutical-Technology
February 15, 2022
Pfizer and BioNTech are set to extend their rolling submission to the US Food and Drug Administration (FDA) for amending the emergency use authorization (EUA) of the Covid-19 vaccine to include children aged six months to four years.
US FDA accepts Spectrum Pharmaceuticals’ poziotinib NDA for review pharmaceutical-business-review
February 14, 2022
The US Food and Drug Administration (FDA) has accepted for review Spectrum Pharmaceuticals’ New Drug Application (NDA) for its therapy poziotinib.

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