FDA Archives

car-t therapy, combination therapy, car-t cell therapy, cancer therapy, blood cancer

More News! 3 Aug 2022

Allarity Therapeutics takes advice from its board and switches focus to combination therapies

US-based Allarity Therapeutics has made a decision to change tack and focus on combination therapy approaches while making the most of its current assets. The company says the new strategy, driven by its board of directors, aligns with the ongoing shift in oncology standard-of-care moving away from monotherapies. Instead it will veer towards more promising […]

August 3, 2022 - 3 minutesmins - By Liza Laws

News and Trends 2 Aug 2022

SNIPR Biome announces new patent granted for applications targeting E. coli infections

SNIPR Biome has today (August 2) announced that it has been granted a patent for medical applications supporting the company’s lead program – a bacteriophage cocktail targeting E.coli infections. Granted by the US Patent and Trademark Office (USPTO), the patent adds to its intellectual property portfolio that contains more than 20 granted patents in the […]

August 2, 2022 - 2 minutesmins - By Liza Laws

News and Trends 1 Aug 2022

Clinical hold on trial for colorectal cancer drug lifted by FDA

A clinical hold has been lifted by the US Food and Drug Administration (FDA) on a trial for a treatment for colorectal cancer after changes were made by the company responsible. Belgium-based Celyad Oncology SA is a clinical biotech company focused on finding and developing chimeric antigen receptor T cell (CAR T) therapies for cancer. […]

August 1, 2022 - 2 minutesmins - By Liza Laws

News and Trends 28 Jul 2022

Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA

A drug to target a rare genetic form of a neurological disease that affects the nerve cells, leading to the loss of everyday functions, could be the first of its kind available if approved. The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Massachusetts-based Biogen Inc. for tofersen, an […]

July 28, 2022 - 4 minutesmins - By Liza Laws

News and Trends 28 Jul 2022

First of a kind multiple sclerosis biosimilar natalizumab accepted by US Food and Drug Association

Sandoz, a global pharmaceutical company working in generic and biosimilar medicines, announced this week that the US Food and Drug Administration (FDA) has accepted its biologics application (BLA) for treatment for people with multiple sclerosis (MS). The application is for a biosimilar natalizumab developed by Polpharma Biologics and includes all indications covered by the reference […]

July 28, 2022 - 3 minutesmins - By Liza Laws

News and Trends 26 Jul 2022

InflaRx announces plans to apply for Emergency Use Authorization for new COVID-19 drug

A biopharmaceutical company developing anti-inflammatory therapeutics announced today (July 26) that it is going to submit a request for Emergency Use Authorization (EUA). InflaRx made the announcement after encouraging interactions with the US Food and Drug Administration (FDA) at a recent meeting. The company had requested the meeting to discuss a potential EUA submission regarding […]

July 26, 2022 - 2 minutesmins - By Liza Laws

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

lupus autoimmune disease neutrophil citryll

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

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