FDA Archives

News and Trends 4 Aug 2022

PolyPid to receive millions for commercialization of infection-fighting drug

A drug to prevent surgical site infections (SSIs) in abdominal and cardiac surgeries in Europe is to be commercialized after two companies entered an exclusive licensing agreement. Israel-based PolyPid Ltd and UK-based ADVANZ PHARMA Corp. announced the agreement for lead drug candidate D-PLEX100 yesterday (August 3). Topline results Under the terms of the agreement, PolyPid will receive […]

August 4, 2022 - 3 minutesmins - By Liza Laws

News and Trends 3 Aug 2022

Patients with advanced cancer set to benefit from ProfoundBio’s new drug

Patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma could benefit from an antibody drug conjugate (ADC) after clearance of an investigational new drug (IND) was approved by the US Food and Drug Administration (FDA). ProfoundBio received the FDA’s ‘study may proceed’ letter today (August 3) to evaluate PRO1184, a folate receptor […]

August 3, 2022 - 2 minutesmins - By Liza Laws

News and Trends 3 Aug 2022

Full label approval given by FDA for eye disease drug, CIMERLI

Age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases can now be treated after the U.S. Food and Drug Administration (FDA) approved a biosimilar product interchangeable with an injection. The approval of CIMERLI (ranibizumab-eqrn) interchangeable with Lucentis, a ranibizumab injection was jointly announced by Polpharma Biologics BV, Formycon AG and Bioeq AG today […]

August 3, 2022 - 4 minutesmins - By Liza Laws

News and Trends 3 Aug 2022

Ascletis announces FDA clearance of oral drug to conduct study in mild to moderate COVID-19 patients

A randomized, placebo-controlled study in mild to moderate COVID-19 patients has been approved by the US Food and Drug Administration (FDA). The Investigational New Drug (IND) application for ASC10, an oral drug candidate targeting RNA-dependent RNA polymerase (RdRp) for COVID-19 was granted to China-based Ascletis Pharma Inc today (August 3), to conduct a Phase 1b […]

August 3, 2022 - 2 minutesmins - By Liza Laws

Sanofi drops amcenestrant clinical development program

News and Trends 3 Aug 2022

Allarity Therapeutics drug no longer commercially viable or in shareholders’ best interest

Allarity Therapeutics, after meeting with the US Food and Drug Administration (FDA), has decided a growth factor receptor drug it licensed from Novartis is no longer commercially viable or in the best interests of its shareholders. A type C advisory meeting was held between Allarity and the FDA to discuss a development path for dovitinib. […]

August 3, 2022 - 4 minutesmins - By Liza Laws

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

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FDA

PolyPid to receive millions for commercialization of infection-fighting drug

Patients with advanced cancer set to benefit from ProfoundBio’s new drug

Full label approval given by FDA for eye disease drug, CIMERLI

Ascletis announces FDA clearance of oral drug to conduct study in mild to moderate COVID-19 patients

Allarity Therapeutics drug no longer commercially viable or in shareholders’ best interest

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

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

Clinical hold on trial for colorectal cancer drug lifted by FDA

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

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

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

New AstraZeneca and Daiichi Sankyo breast cancer drug accepted by FDA

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Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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