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FDA Approvals: September 2022 Recap

Digital Pharmacist

The FDA protects public health by ensuring the efficacy and safety of human and veterinary drugs, including biological products and medical devices. It is critical for the FDA to continue to develop new advances in therapies to aid our communities in order to achieve better lives through better health. Date of Approval: 9/30/2022.

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FDA approves first capsid inhibitor for HIV

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Gilead’s Sunlenca (lenacapavir), a capsid inhibitor for adults living with human immunodeficiency virus type 1 (HIV-1), who cannot be successfully treated with other available treatments. After 52 weeks, 83 percent of participants continued to have HIV RNA suppression.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

This can be achieved by reducing the burden of adverse reactions or by optimising benefits through patient selection (eg, contraindications, recommendations of use, warnings, concomitant medicine[s], or certain test parameters) and treatment management (eg, specific dosing regimen, relevant testing, patient follow-up). References.

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BeiGene’s Brukinsa FDA approved for CLL/SLL

pharmaphorum

Beijing-based pharma, BeiGene’s Brukinsa (zanubrutinib) has been approved by the US Food and Drug Administration (FDA) for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The post BeiGene’s Brukinsa FDA approved for CLL/SLL appeared first on. of patients.

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FDA Unveils Its Own Medical Queries—A Standardized Approach for Grouping MedDRA Preferred Terms that Will Impact NDA/BLA Safety Analyses and Drug Labeling

The FDA Law Blog

By Ellis Unger, Principal Drug Regulatory Expert — On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics , including sessions on new FDA Medical Queries and standardized presentations of safety data.

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US FDA approves AbbVie-Janssen’s Imbruvica for cGVHD in children

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has gra nted approval for AbbVie and Janssen Biotech’s Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD) in paediatric patients aged one year and above. The post US FDA approves AbbVie-Janssen’s Imbruvica for cGVHD in children appeared first on Pharmaceutical Technology.

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Gabapentin side effects in men

The Checkup by Singlecare

In fact, its kind of a jack-of-all-trades drug, approved by the Food and Drug Administration (FDA) to treat epilepsy, postherpetic neuralgia, and restless leg syndrome. Research backs up the idea that women are actually more likely to experience gabapentins adverse effects than men. Those side effects, however, are largely similar.