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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).
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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).
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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.
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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.
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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.
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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 ...
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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 ...
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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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FDA refuses Novo Nordisk’s once-weekly semaglutide
pharmatimes
March 25, 2021
Novo Nordisk has received a refusal to file letter from the US Food and Drug Administration (FDA) for a label expansion application for semaglutide.
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FDA Authorizes Revisions to Fact Sheets for SARS-CoV-2 Variants under EUA
americanpharmaceuticalreview
March 25, 2021
The U.S. Food and Drug Administration (FDA) authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available ...