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Strides gets USFDA nod for Oxybutynin Chloride Tablets expresspharma
December 21, 2020
Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the United States Food & Drug Administration (USFDA).
Lupin gets US FDA approval for Colesevelam Hydrochloride Tablets expresspharma
December 21, 2020
They are indicated for reducing elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
US FDA gives EUA to Moderna’s mRNA vaccine against COVID-19 expresspharma
December 21, 2020
Total of 200 million doses ordered by the US government to date, approximately 20 million doses will be delivered by the end of December 2020.
US FDA declines approval for Novartis’ inclisiran expresspharma
December 21, 2020
The drug regulator cited unresolved facility inspection issues for denying approval.
FDA Authorizes BinaxNOW COVID-19 Ag Card Home Test americanpharmaceuticalreview
December 18, 2020
The U.S. Food and Drug Administration (FDA) issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription.
Trial to Assess Pulsed Field Ablation System for AFib Receives FDA Conditional Approval americanpharmaceuticalreview
December 18, 2020
FARAPULSE announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company's Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its ...
FDA Approves Rare Pediatric Disease Designations for WP1066 americanpharmaceuticalreview
December 18, 2020
Moleculin Biotech announced the US Food and Drug Administration (FDA) has approved its request for a "Rare Pediatric Disease" designation for its drug candidate WP1066.
US FDA Advisory Committee supports EUA for Moderna’s COVID-19 vaccine expresspharma
December 18, 2020
Moderna confirmed that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an emergency use authorisation (EUA) for the company’s COVID-19 vaccine candidate ...
FDA Authorizes Antigen Test as First OTC At-Home COVID-19 Diagnostic Test americanpharmaceuticalreview
December 17, 2020
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19.
British American Tobacco’s COVID-19 vaccine candidate from gets US FDA nod for human trials expresspharma
December 17, 2020
The enrolment for the study is expected to start shortly, with results likely by mid-2021, the company said.

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