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US FDA Grants Moleculin Orphan Drug Designation of WP1122 to Treat Glioblastoma Multiforme

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation of WP1122 to Moleculin Biotech, Inc., a clinical-stage pharmaceutical company, for the treatment of Glioblastoma Multiforme (GBM). Walter Klemp, chairman and CEO of Moleculin Biotech, Inc., said the receipt of Orphan Drug Designation is represents an important milestone for

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Pfizer, BioNTech Seeks EUA from US FDA for Omicron Adapted COVID-19 Vaccine

Pfizer Inc. and BioNTech announced they have completed a submission to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron adapted bivalent COVID-19 vaccine for individuals over 12 years. This application follows guidance from the US FDA to include clinical

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AstraZeneca Enhertu Secures US FDA Approval for HER2-Low Breast Cancer

The US Food and Drug Administration (FDA) has approved Enhertu of AstraZeneca and Daiichi Sankyo for the treatment of adult patients with metastatic HER2-low breast cancer, who have received a prior chemotherapy in the metastatic setting during six months of completing adjuvant chemotherapy. Enhertu is a specifically designed HER2-directed antibody drug

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Hyundai Bioscience To Request US FDA a Fast Track Processing For Its Monkeypox Treatment Drug

Hyundai Bioscience is going straight to the United States FDA along with the company’s broad-spectrum antiviral drug candidate for the purpose of treating the monkeypox disease. The company has decided for submitting a request for a fast track processing to the Food and Drug Administration (FDA) of the United States

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US FDA Approves sBLA of Pfizer for ABRILADA Interchangeability

The pharmaceutical company ‘Pfizer Inc.’ has now announced that, the US FDA has given approval for the reviewing the PAS (Prior Approval Supplement) to the BLA (Biologics License Application) for the ABRILADA as an interchangeable biosimilar to the Humira. Mike Gladstone, president of inflammation and immunology at Pfizer said, an interchangeability

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Lupin Pharmaceuticals Gets US FDA Nod for Its Renvela Generic Medicine

The pharmaceutical company ‘Lupin’ said that, it has successfully received the approval from the Food and Drug Administration (FDA) of the United States for the company’s ANDA (abbreviated new drug application) Sevelamer Carbonate for the oral suspension. This drug or medicine has been a generic equivalent of the Renvela for

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