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FDA approves first treatment for geographic atrophy

European Pharmaceutical Review

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. A milestone for retinal ophthalmology The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade.”

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FDA approves GSK’s Blenrep for advanced multiple myeloma

pharmaphorum

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population and included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%) and dry eye (19%).

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes. Along those lines, the new draft guidance does not contain any language regarding DMCs not being appropriate for early phase studies.

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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 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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ViiV/J&J’s long-acting HIV regimen finally approved in US

pharmaphorum

The FDA has approved Cabenuva, a long-acting HIV treatment from ViiV and Johnson & Johnson that keeps the virus at bay with a monthly injection instead of daily pill regimen. The clinical data supplied by ViiV was enough to support approval, however, and the FDA has finally given the go-ahead for Cabenuva.

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bluebird seeks gene therapy trial restart after cancer scare

pharmaphorum

If regulators such as the FDA accept the findings it will also leave bluebird free to continue negotiations with NICE over funding in England and Wales to treat beta thalassemia after an initial rejection. He added: “We have seen no significant gene misregulation attributable to the insertion event. “In