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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.
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 ...
Glenmark Pharma gets ANDA approval for chlorpromazine hydrochloride tablets expresspharma
March 25, 2021
Granted competitive generic therapy designation and is eligible for 180 days of CGT exclusivity.
Indian drug manufacturer sentenced to pay USD 50 million in fines expresspharma
March 25, 2021
Fresenius Kabi Oncology was previously criminally charged by the United States with violating the Federal Food, Drug and Cosmetic Act.
Forest Hills Lab is filing an IND to initiate a clinical phase 2 study on Parkinson's disease with the US FDA prnasia
March 24, 2021
Forest Hills Partners Hong Kong, S.A.R., China Limited (also known as Forest Hills Lab) is ready to file an Investigative New Drug (IND) application with the US FDA in April 2021 to assess tolerability and efficacy with one of its drug candidates, namely
FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process americanpharmaceuticalreview
March 24, 2021
The U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and ...
FDA approves Zealand Pharma’s Zegalogue for hypoglycemia treatment pharmaceutical-business-review
March 24, 2021
Zealand Pharma has announced the US Food and Drug Administration (FDA) approval of its Zegalogue (dasiglucagon) injection for the treatment of patients aged six and above with severe hypoglycemia.
FDA approves emergency use of a non-diagnostic COVID-19 screening device europeanpharmaceuticalreview
March 23, 2021
The Tiger Tech COVID Plus Monitor was granted Emergency Use Authorization (EUA) based on its ability to detect biomarkers indicative of COVID-19 infection in asymptomatic individuals.
Ambrx gets orphan drug designation for gastric cancer treatment ARX788 pharmaceutical-business-review
March 23, 2021
The US Food and Drug Administration (FDA) grants orphan drug designation to Ambrx for ARX788, a homogeneous and highly stable antibody drug conjugate, for the treatment of HER2-positive gastric cancer.
US FDA approves Janssen’s PONVORY for relapsing multiple sclerosis pharmaceutical-technology
March 23, 2021
The US Food and Drug Administration (FDA) has approved the Janssen Pharmaceutical Companies of Johnson & Johnson’s (JNJ) PONVORY (ponesimod) for treating adults with relapsing forms of multiple sclerosis (MS).

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