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Results For "U.S"

1563 News Found

Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue
Biotech | December 07, 2021

Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue

The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects


Morpen gets U.S. FDA approval for Fexofinadine
Drug Approval | December 05, 2021

Morpen gets U.S. FDA approval for Fexofinadine

Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever


U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib
Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)


U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery
Drug Approval | November 30, 2021

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal


Aadi Bioscience secures U.S FDA approval of its first product Fyarro
Drug Approval | November 26, 2021

Aadi Bioscience secures U.S FDA approval of its first product Fyarro

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults


U.S. FDA approves first treatment for drug-resistant post-transplant infection
Drug Approval | November 24, 2021

U.S. FDA approves first treatment for drug-resistant post-transplant infection

The approval is for Cytomegalovirus, a type of Herpes virus


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
Drug Approval | November 23, 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies


Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules
Drug Approval | November 23, 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years