News about "US Food and Drug Administration "

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 |  160

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

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 |  149

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 |  231

La Chandra Pharmalab Secures US FDA Clearance for Gujarat Hormone API Facility

La Chandra Pharmalab has received a US FDA Establishment Inspection Report (EIR) for its Banaskantha hormone API manufacturing facility, reinforcing its position in regulated markets and advancing India's capabilities in hormone API manufacturing.

US Food And Drug Administration | 03/07/2026 | By News Bureau |  134

Roche's Enspryng Receives FDA Priority Review for Thyroid Eye Disease

Roche's Enspryng has received FDA Priority Review for thyroid eye disease after Phase 3 studies demonstrated clinically meaningful improvements in eye bulging, disease activity and double vision, with a regulatory decision expected by October 2026.

US Food And Drug Administration | 01/07/2026 | By News Bureau |  103

Nuvation Bio's Taletrectinib Advances UK Regulatory Review for ROS1-Positive Lung Cancer

The UK's MHRA has validated the marketing application for Nuvation Bio's taletrectinib, bringing the next-generation ROS1 inhibitor one step closer to approval for patients with advanced ROS1-positive non-small cell lung cancer in the UK.

US Food And Drug Administration | 01/07/2026 | By News Bureau

Sobi Receives FDA Complete Response Letter for Experimental Gout Therapy NASP

Sobi has received a Complete Response Letter from the US FDA for its investigational gout therapy NASP, with the regulator requesting additional manufacturing data and facility-related information before considering approval. The company plans to work with the FDA and its manufacturing partners toward resubmitting the application.

US Food And Drug Administration | 29/06/2026 | By News Bureau

Allergan Aesthetics Secures FDA Approval for Skinvive by Juvederm to Treat Neck Wrinkles

Allergan Aesthetics, an AbbVie company, has received US FDA approval for Skinvive by Juvéderm to reduce neck wrinkles and improve overall neck appearance.

US Food And Drug Administration | 18/06/2026 | By News Bureau