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News about "US Food and Drug Administration "
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
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 | 146
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
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
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
Sunrise Air Receives US FDA Clearance, Expanding Access to At-Home Sleep Apnoea Diagnosis
Sunrise Air, Sunrise Group’s FDA-cleared next-generation home sleep testing device, combines AI-powered analysis and advanced sensor technology to deliver accessible, clinically robust sleep apnoea diagnosis from home.
US Food And Drug Administration | 21/05/2026 | By News Bureau | 123
US FDA Upgrades AI Systems, Launches HALO Data Platform to Modernise Regulatory Operations
FDA unveils Elsa 4.0 AI upgrade and consolidates over 40 data systems into the new HALO platform to streamline workflows, enhance regulatory science and accelerate treatment approvals.
US Food And Drug Administration | 08/05/2026 | By News Bureau | 418
Boston Cell Standards Advances Cancer Testing Tools into FDA Qualification Phase
Boston Cell Standards moves closer to standardising cancer diagnostics as its IHC reference tools enter FDA qualification, aiming to improve accuracy and accelerate therapy development.
U.S. Food And Drug Administration | 29/04/2026 | By News Bureau | 114
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