FDA Archives

News and Trends 26 Jul 2022

New AstraZeneca and Daiichi Sankyo breast cancer drug accepted by FDA

A drug candidate for unresectable or metastatic breast cancer has been accepted by the US Food and Drug Administration (FDA). The drug is being jointly developed and commercialized and the result of a high-profile partnership between AstraZeneca and Daiichi Sankyo. Enhertu (trastuzumab deruxtecan) is a specifically engineered HER2-directed antibody drug conjugate (ADC). Acceptance The companies received […]

July 26, 2022 - 3 minutesmins - By Liza Laws

News and Trends 25 Jul 2022

Drug that could be the first and only in Europe to treat rare brain condition recommended for marketing authorization

The Committee for Medical Products for Human Use (CHMP) has recommended the European Commission (EC) make a marketing authorization under exceptional circumstances for a drug to treat a rare condition characterized by brain dysfunction. The drug is called NULIBRY (fosdenopterin) for injection therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. […]

July 25, 2022 - 4 minutesmins - By Liza Laws

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News and Trends 22 Jul 2022

Positive news for Aurinia’s voclosporin drug Lupkynis to treat lupus nephritis

British Columbia-based Aurinia Pharmaceuticals Inc. announced today (July 22) that its voclosporin drug has been recommended for marketing authorization to treat adults with active lupus nephritis (LN). The Canadian biopharma company said it is committed to delivering therapeutics that change the course of autoimmune disease after the Committee for Medicinal Products for Human Use (CHMP) […]

July 22, 2022 - 3 minutesmins - By Liza Laws

News and Trends 19 Jul 2022

Good news for Destiny Pharma’s nasal gel to combat life-threatening infections

Clinical stage biotech company, Destiny Pharma, announced today (July 19) a positive update from the U.S. Food and Drug Administration (FDA) on its XF-73 nasal gel phase 3 development plans. The FDA has clarified the phase 3 and U.S. registration pathway for the gel for the prevention of post-surgical staphylococcal infections, and this feedback enables […]

July 19, 2022 - 5 minutesmins - By Liza Laws

News and Trends 11 Jul 2022

Treatment for cancer-associated thrombosis fast-tracked by FDA

A clinical-stage biotechnology company that develops therapies for cardiovascular and metabolic diseases today (July 11) announced it has been granted fast track designation by the US Food and Drug Administration (FDA) for a treatment for thrombosis associated with cancer. Anthos Therapeutics focuses on the development and commercialization of drugs and abelacimab is a new, highly […]

July 11, 2022 - 4 minutesmins - By Liza Laws

News and Trends 8 Jul 2022

New drug application for treatment of dry eyes disease submitted to FDA

A treatment for dry eye symptoms associated with Meibomian gland dysfunction (MGD) has been submitted under a New Drug Application (NDA) and will be considered by the US Food and Drug Administration. The application was submitted at the end of last month (June) by the Canada-based global eye health company, Bausch and Lomb Corporation, and […]

July 8, 2022 - 2 minutesmins - By Liza Laws

News and Trends 27 Jun 2022

Eye inflammation leads to FDA partial clinical hold on Nuvation Bio solid tumor study

U.S. biopharma company Nuvation Bio Inc. says the Food and Drug Administration (FDA) has placed a partial clinical hold on the company’s phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. The company’s Phase 1 trial began enrolling patients in […]

June 27, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 27 Jun 2022

Trial for adults with late onset Pompe disease halted due to serious adverse event

The US Food and Drug Administration (FDA) has placed a clinical hold on a trial being run for Astrellas Pharma Inc after one of the participants had a serious adverse event (SAE) of peripheral sensory neuropathy. Astrellas made the announcement after the trial, which is evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement in […]

June 27, 2022 - 3 minutesmins - By Liza Laws

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

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FDA

New AstraZeneca and Daiichi Sankyo breast cancer drug accepted by FDA

Drug that could be the first and only in Europe to treat rare brain condition recommended for marketing authorization

Positive news for Aurinia’s voclosporin drug Lupkynis to treat lupus nephritis

Good news for Destiny Pharma’s nasal gel to combat life-threatening infections

Treatment for cancer-associated thrombosis fast-tracked by FDA

New drug application for treatment of dry eyes disease submitted to FDA

Eye inflammation leads to FDA partial clinical hold on Nuvation Bio solid tumor study

Trial for adults with late onset Pompe disease halted due to serious adverse event

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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