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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.
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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.
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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
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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 ...
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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.
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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.
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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.
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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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FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis
pharmatimes
March 22, 2021
The US Food and Drug Administration (FDA) has approved Kiniksa Pharmaceuticals’ interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) inhibitor Arcalyst (rilonacept) for the treatment of recurrent pericarditis and reduction in risk of recurrence ...
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FDA Releases Updated Essure Report
americanpharmaceuticalreview
March 22, 2021
The U.S. Food and Drug Administration (FDA) posted the seventh spreadsheet of reportable adverse events that Bayer is required to submit as outlined in the April 24, 2020 variance from MDR reporting requirements.