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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In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s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.
FDA Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives to Opioids for Acute Pain Management FDA
February 11, 2022
The U.S. Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction.
U.S. Buys 600,000 Doses of New COVID-19 Treatment Still Awaiting FDA Approval drugs.com
February 11, 2022
The U.S. government has bought 600,000 doses of a new antibody drug called bebtelovimab that seems able to beat back the omicron...
FDA Postpones Decision on Pfizer COVID-19 Vaccine for Under 5s drugs.com
February 11, 2022
The U.S. Food and Drug Administration announced Friday that it will postpone an advisory panel meeting.

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