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3003 News Found

LG Chem’s new drug for obesity receives additional orphan drug designation by US FDA
News | June 16, 2022

LG Chem’s new drug for obesity receives additional orphan drug designation by US FDA

With this designation, LG Chem will receive benefits such as exclusive sales rights in the US market for seven years, subsidies and tax cuts for clinical testing costs in the US, and preliminary consulting support related to development


Eli Lilly gets FDA approval for alopecia drug
Drug Approval | June 15, 2022

Eli Lilly gets FDA approval for alopecia drug

Alopecia areata usually presents as a few small bald patches in the head


Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis
Drug Approval | June 09, 2022

Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis

TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.


FDA publishes ANP’s polymeric drug excipient DMF
Drug Approval | June 06, 2022

FDA publishes ANP’s polymeric drug excipient DMF

The DMF#36513 demonstrates ANP’s success in the development of its “Plug and Play” drug delivery platform.


US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027
Drug Approval | June 01, 2022

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study


Next-gen immunotherapy drug shows promise in several advanced-stage cancers
Biotech | May 27, 2022

Next-gen immunotherapy drug shows promise in several advanced-stage cancers

Researchers found that the drug combination led to a sustained and tenfold increase in the production of CD8 T cells and natural killer cells


Excelra Partners with HotSpot Therapeutics to enhance allosteric drug discovery efforts
Biotech | May 26, 2022

Excelra Partners with HotSpot Therapeutics to enhance allosteric drug discovery efforts

The partnership aims to enhance HotSpot's drug discovery and development efforts by incorporating GOSTAR's high-quality, annotated datasets into HotSpot's machine learning (ML) and artificial intelligence (AI) models


USFDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain
Supply Chain | May 20, 2022

USFDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain

Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages


Sun Pharma to launch Brillo, a first-in-class oral lipid-lowering drug in India
Drug Approval | May 18, 2022

Sun Pharma to launch Brillo, a first-in-class oral lipid-lowering drug in India

Bempedoic Acid administered as a 180-mg dose, is approved by the USFDA and European Union for the treatment of hypercholesterolemia