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US FDA approves Apellis’ geographic atrophy therapy Syfovre

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology.

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

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FDA approves first gene therapy for high-risk early bladder cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours.

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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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Magenta Therapeutics Pauses the P-I/II Study in AML Patients

PharmaShots

Ref: GlobeNewswire | Image: Magenta Therapeutics Related News:- AC Immune Reports Results of ACI-24.060 in P-Ib/II Trial for the Treatment of Alzheimer’s Disease and Down Syndrome Shots: The participant from the P-I/II dose-escalation, study dosed MGTA-117 at the Cohort 3 level (0.08

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FDA slaps hold on trials of Gilead’s CD47 drug magrolimab

pharmaphorum

The FDA has placed a partial clinical fold on clinical trials of Gilead Sciences’ magrolimab, the centre piece of its $4.9 Other research suggests it my also play downgrade immune responses by cell-killing T cells as well as dendritic cells, which are involved in antibody responses, making it a compelling target for drug developers.

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It’s been a long time coming for long-term topical psoriasis treatments

pharmaphorum

Anyone who watches television has heard the list of potential adverse reactions, considering that commercials for psoriasis treatments are seemingly only outnumbered by goofy ads for auto insurance. For moderate to severe cases, systemic biologics work to suppress the immune system and bring relief to the skin and joints.