News about "US Food and Drug Administration "

Alvotech Gets FDA Approval for Second AVT02 Manufacturing Suite

Alvotech receives FDA approval to manufacture AVT02 drug substance in its second Reykjavik production suite.

US Food And Drug Administration | 06/10/2026 | By News Bureau

CSL, Alentis Sign Global Deal to Develop Lixudebart

CSL and Alentis enters an exclusive global collaboration to advance lixudebart across kidney and liver diseases.

US Food And Drug Administration | 06/10/2026 | By News Bureau

Edwards' AUTUS Valve Receives US FDA Approval for Paediatric Use

Edwards Lifesciences receives FDA approval for its growth-adjustable AUTUS pulmonary valve for paediatric patients.

US Food And Drug Administration | 05/10/2026 | By News Bureau

Mirum's Brelovitug Meets Phase 3 Endpoint in Chronic Hepatitis Delta

Mirum Pharmaceuticals reports positive Phase 3 AZURE-1 results for brelovitug, with the investigational antibody meeting its primary endpoint in chronic HDV.

US Food And Drug Administration | 29/09/2026 | By News Bureau

Xenon Submits NDA for Azetukalner in Focal Seizures to US FDA

Xenon Pharmaceuticals has submitted an NDA to the US FDA for azetukalner in focal seizures, supported by data from the Phase 2b X-TOLE and Phase 3 X-TOLE2 trials.

US Food And Drug Administration | 21/09/2026 | By News Bureau |  105

Aurobindo Pharma Unit Receives US FDA Warning Letter; No Impact on US Supplies

Aurobindo Pharma’s Eugia Pharma Specialities has received a US FDA warning letter for its Telangana facility, while the company said existing US supplies remain unaffected.

US Food And Drug Administration | 14/08/2026 | By News Bureau |  221

US FDA Proposes New Rule to Modernise Drug Manufacturing Registration

The US Food and Drug Administration (FDA) has proposed a new rule to modernise drug manufacturing registration, streamline advanced distributed manufacturing, and improve visibility into foreign drug supply chains.

US Food And Drug Administration | 13/07/2026 | By News Bureau

Orchid Pharma Partners with Pharmasyntez to Commercialise Exblifep in Russia

Orchid Pharma has signed an exclusive licensing and supply agreement with Pharmasyntez JSC for Exblifep in Russia. The partnership is expected to strengthen access to advanced antimicrobial therapies while addressing the growing challenge of antibiotic resistance.

US Food And Drug Administration | 09/07/2026 | By News Bureau |  132

Vertex to Acquire Crinetics Pharmaceuticals for USD 10 Billion

Under the terms of the agreement, Vertex will acquire all outstanding shares of Crinetics for USD 85 per share in cash, representing a net transaction value of approximately USD 8.8 billion after accounting for estimated cash acquired.

US Food And Drug Administration | 08/07/2026 | By Abha |  216

INTENT Biologics Secures FDA Breakthrough Therapy Tag for Diabetic Foot Ulcer Treatment Candidate

INTENT Biologics' PEP Biologic receives FDA Breakthrough Therapy designation for diabetic foot ulcers, accelerating development of its first-in-class exosome-based regenerative treatment aimed at improving healing outcomes in chronic wounds.

US Food And Drug Administration | 03/07/2026 | By News Bureau |  283