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Bayer gets Lampit FDA approval for Chagas disease in pediatric patients

Bayer gets Lampit FDA approval for Chagas disease in pediatric patients

Lampit FDA approval : Bayer has bagged approval for its antiprotozoal medication Lampit (nifurtimox) from the US Food and Drug Administration (FDA) for the treatment of Chagas disease in pediatric patients, from newly born to less than 18 years of age, weighing at least 2.5kg. Chagas disease is an infectious tropical disease caused by Trypanosoma […]

CHMP adopts positive opinion for avapritinib for PDGFRA D842V mutant GIST

US precision therapy company Blueprint Medicines said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for avapritinib as a monotherapy for certain types of gastrointestinal stromal tumors (GIST). CHMP has recommended conditional marketing authorization of the kinase inhibitor in the European Union for […]

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Farxiga : AstraZeneca gets FDA fast track status for heart failure after MI

AstraZeneca has secured fast track designation for Farxiga (dapagliflozin) in the US for its use in reducing the risk of hospitalization for heart failure (hHF) or cardiovascular (CV) death in adults after an acute myocardial infarction (MI) or heart attack. The fast track designation for the oral once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor is based on […]

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Chinese regulator accepts NDA of BeiGene’s pamiparib in ovarian cancer

BeiGene said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of pamiparib for the treatment of certain ovarian cancer patients. Pamiparib is an investigational inhibitor of PARP1 and PARP2 and its NDA is for patients having deleterious or suspected deleterious germline […]

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Ascentage Pharma gets FDA ODD for APG-2575 in Waldenström macroglobulinemia

Ascentage Pharma has been granted orphan drug designation (ODD) for its Bcl-2 inhibitor APG-2575 from the US Food and Drug Administration (FDA) for the treatment of Waldenström macroglobulinemia (WM). The orally administered Bcl-2 selective inhibitor that has been designed for the treatment of a range of hematologic malignancies by selectively inhibiting Bcl-2 to restore the […]

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BNT162b1 and BNT162b2 Covid-19 vaccine candidates get FDA fast track status

Pfizer and BioNTech said that BNT162b1 and BNT162b2, two vaccine candidates developed to give protection against the SARS-CoV-2 virus have been given the fast track designation from the USFood and Drug Administration (FDA). The two vaccine candidates are part of the four investigational vaccine candidates that are being jointly developed by the companies under their […]

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Gilead Sciences announces Veklury EU approval for COVID-19 treatment

Veklury EU approval : Gilead Sciences said that Veklury (remdesivir) has been given conditional marketing authorization from the European Commission as a treatment for SARS-CoV-2 infection, the virus behind COVID-19. According to the US pharma company, the conditional marketing authorization for Veklury was given in the interest of public health because of the coronavirus pandemic […]

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ViiV Healthcare bags Rukobia FDA approval for HIV patients with limited treatment options

Rukobia FDA approval : ViiV Healthcare said that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets as a new treatment of HIV patients having limited treatment options. According to the FDA, Rukobia is a new type of antiretroviral medication for adult HIV patients who tried various HIV medications […]

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Medivir gets orphan medicinal product designation for MIV-818 for HCC in EU

Swedish biotech company Medivir has secured orphan medicinal product designation from the European Commission for MIV-818 for the treatment of hepatocellular carcinoma (HCC). The orphan medicinal product designation to the pro-drug in the European Union (EU) was granted in accordance with the opinion from the European Medicines Agency (EMA). Although hepatocellular carcinoma is considered to […]

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Zogenix bags Fintepla FDA approval for Dravet syndrome treatment

Fintepla FDA approval : Zogenix has bagged approval from the US Food and Drug Administration (FDA) for Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients aged two years of age and older. Considered to be a life-threatening, rare and chronic type of epilepsy, Dravet syndrome is usually […]

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