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BIOVAXYS files FDA pre-IND meeting request and briefing package for COVID-T prnasia
March 31, 2021
BioVaxys Technology Corp., the world leader in haptenized antigen vaccines for antiviral and cancer applications, announced today that it is has filed a pre-IND (Investigational New Drug) meeting request and submitted a briefing package with the ...
Amphastar Receives FDA Approval for Dextrose Injection americanpharmaceuticalreview
March 30, 2021
Amphastar Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved the Company’s Abbreviated New Drug Application (ANDA) for Dextrose injection 50% in the 50 mL Luer-Jet® Prefilled Syringe System.
FDA Approves two Octapharma Supplements americanpharmaceuticalreview
March 30, 2021
The U.S. Food and Drug Administration (FDA) has approved two Octapharma supplements to Biological License Applications (BLA).
FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief americanpharmaceuticalreview
March 29, 2021
The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA panel votes against Pfizer’s tanezumab for osteoarthritis pain pharmaceutical-technology
March 29, 2021
A joint FDA advisory committee has rejected a risk mitigation proposal for Pfizer and Eli Lilly’s osteoarthritis (OA) drug tanezumab, concluding that the drug’s safety risk to patients is too high.
Bristol Myers Squibb and bluebird bio get US FDA nod for Abecma (idecabtagene vicleucel) to treat relapsed or refractory multiple myeloma expresspharma
March 29, 2021
Abecma is a first-in-class BCMA-directed personalised immune cell therapy delivered as a one-time infusion for triple-class exposed patients with multiple myeloma.
FDA Advises Health Care Professionals Not to Use ChloraPrep 3 mL BD Applicators americanpharmaceuticalreview
March 26, 2021
The U.S. Food and Drug Administration (FDA) advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company), due to microbial contamination risks.
FDA Authorizes First Machine Learning-Based Screening Device that May Indicate COVID-19 Infection americanpharmaceuticalreview
March 26, 2021
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are ...
FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma americanpharmaceuticalreview
March 26, 2021
The U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or ...
FDA sends warning to companies selling unapproved CBD products europeanpharmaceuticalreview
March 25, 2021
The warning letters were issued to two companies illegally selling over-the-counter cannabidiol (CBD) products for pain relief.

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