Remove Adverse Reactions Remove Events Remove FDA
article thumbnail

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.”

FDA 98
article thumbnail

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. Clinical study of Adstiladrin.

FDA 110
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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.

article thumbnail

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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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 Along those lines, the new draft guidance does not contain any language regarding DMCs not being appropriate for early phase studies.

article thumbnail

Xdemvy side effects and how to avoid them

The Checkup by Singlecare

Food and Drug Administration (FDA) in July of 2023 to treat Demodex blepharitis (inflammation of the eyelids). Manufactured by Tarsus Pharmaceuticals, it is the only FDA-approved treatment that targets and kills Demodex mites that cause Demodex blepharitis. Like all medications, side effects may occur when taking Xdemvy.

article thumbnail

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.

FDA 75
article thumbnail

AZ, J&J COVID-19 vaccine trials okay to restart in US

pharmaphorum

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot. There are many possible factors that could have caused the event.”.