Children and adults with a type of congenital hearing loss now have a free treatment option, with the U.S. FDA’s accelerated approval of Regeneron Pharmaceuticals Inc.’s DB-OTO, an AAV-mediated gene therapy. Branded Otarmeni (lunsotogene parvec), it is cleared specifically for hearing loss caused by variants in the otoferlin gene. Read More
As Sanofi SA gets ready to welcome a new CEO, the company along with partner Regeneron Pharmaceuticals Inc. said a happy hello as well to robust sales of Dupixent (dupilumab, dupi) and gained U.S. FDA clearance for the IL-4 receptor alpha antagonist to treat children, ages 2 to 11, with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment. Read More
Artificial intelligence tools are springing up at multiple points along drug discovery and development, but despite the hype, as yet there is minimal return on investment (ROI). “I would say a lot of companies sort of get this big excitement about AI, but then when you look at how much ROI they get, it’s actually very little. And that’s because the workflow and the process, end-to-end, isn’t mapped to really understand where AI can truly make an impact,” said Laura Matz, chief science and technology officer at Merck KGaA. Read More
The first fully robot-assisted cataract surgery recently performed using Forsight Robotics Ltd.’s Jasper platform was not only a “transformative” event and a major “milestone” for the company, but also a “huge step forward for the industry,” Joseph Nathan, co-founder, president and chief medical officer, told BioWorld. With one in two people globally needing cataract surgery and unable to get access to care, robot-assisted platforms hold the potential to increase surgical throughput and broaden access to treatment. Read More
Shares in Aussie hearing implant maker Cochlear Ltd. plummeted nearly 39% April 22 after the company slashed fiscal 2026 earnings guidance and warned that weaker-than-expected demand in developed markets was exposing a more cyclical and discretionary side to its business than investors had assumed. Read More
The U.S. FDA and CMS are teaming up to give Medicare beneficiaries quicker access to breakthrough medical devices and provide manufacturers with certainty of reimbursement. Read More
Biopharma deal value reached $79.22 billion in the first quarter (Q1) 2026, marking a strong start to the year and an increase of about 17% from $67.6 billion in Q1 2025 and similar to $78.93 billion in Q4 2025. The total is the highest first-quarter tally in recent years, and the highest quarter since Q4 2025 brought $80.65 billion. Read More
The U.S. FDA’s recent pledge to make public complete response letters (CRLs) for drugs and biologics that failed to gain approval has encountered some objections from industry regarding the potential for disclosure of trade secrets and proprietary information. Read More
New hires and promotions in the biopharma and med-tech industries, including: 908 Devices, Biomarin, Bridgebio, Curacell, Elkedonia, Humacyte, Jad, Novabridge, PMV, Tenax, Trethera. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Maze, Milestone, Nektar, Outlook, Preveceutical, Tarsier, Tuhura. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Amneal, Arcus, Gilead, Eli Lilly, Kashiv, Odyssey, Rigel. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: 4Moving Biotech, Belite Bio, Ipsen, Johnson & Johnson, Merck, Sanofi, Sonorous, Vapotherm, Veloxis. Read More
