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Artivion Secures US FDA Approval for AMDS Hybrid Prosthesis to Treat Acute Aortic Dissections
Artivion has received US FDA approval for its AMDS Hybrid Prosthesis, enabling broader adoption of the aortic arch remodelling device that has demonstrated significant reductions in mortality and major complications for patients with acute DeBakey Type I aortic dissections.
Jagsonpal Pharmaceuticals to Acquire 85 Percent Stake in Aequitas Healthcare for INR 20.8 Crore
Aeguitas Healthcare’s acquisition marks Jagsonpal's entry into the hospital pharmaceutical segment, strengthening its omnichannel healthcare strategy and expanding its institutional market presence.
Viatris Reports Positive Phase 3 Results for VR-205 in IgA Nephropathy in Japan
Viatris reported positive Phase 3 results for VR-205 in Japanese adults with primary IgA nephropathy and plans to submit a New Drug Application (NDA) in Japan by the end of 2026.
Cadila Pharmaceuticals and Singapore-based Wellesta Holdings have signed an MoU to establish a joint venture focused on expanding access to high-quality healthcare solutions across Southeast Asia and other emerging markets.
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.
Sanofi's Nexviazyme Meets Primary Goal in Phase 3 Study for Infantile-Onset Pompe Disease
Sanofi's Phase 3 Baby-COMET study showed Nexviazyme improved ventilator-free survival in infants with infantile-onset Pompe disease, supporting plans for a US regulatory filing to expand the therapy's approved indication.
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.
Health Minister Nadda Launches National Drug Registry
Union Health Minister JP Nadda has launched the National Drug Registry to standardise medicine information, enhancing transparency, trust, and seamless access to drug data across India.
Morepen Begins Commercial Supplies under INR 825 Crore CDMO Contract
Morepen has started commercial supplies under its INR 825 crore CDMO mandate, completing the first INR 50 crore dispatch in Q1 FY2026-27 and strengthening its contract manufacturing business.
US FDA approves Viridian's Lumvoa for treatment of thyroid eye disease
Viridian Therapeutics secures US FDA approval for Lumvoa, the first IGF-1R antagonist approved to treat both active and chronic thyroid eye disease, with commercial launch set to begin immediately.
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