Regulatory Approval

Spectral Medical shifts its FDA submission for a breakthrough sepsis device, a strategic move that could strengthen its case but delays a potential lifeline.

With a key FDA decision looming and pivotal data on a second therapy imminent, Viridian is poised to reshape the multi-billion dollar Thyroid Eye Disease market.

With soaring sales for its rare obesity drug IMCIVREE, Rhythm Pharmaceuticals faces a critical March FDA decision that could unlock a massive new market.

Eton Pharmaceuticals wins landmark FDA approval for DESMODA, a breakthrough liquid drug set to transform care for a rare condition by enabling precise, safe dosing.

A new oral drug shows remarkable success in healing stubborn herpes lesions in people with HIV, offering a much-needed breakthrough for a vulnerable population.

Cara Medical's AI-powered CARA System gets FDA approval, promising to revolutionize complex heart procedures with 3D visualization of the conduction system.

Curanex Pharmaceuticals hits a key manufacturing milestone for Phyto-N, a botanical drug with a 30-year history, advancing its quest for FDA approval.

New subgroup data from ITM's COMPETE trial could refine treatment for a tough-to-treat cancer and bolster the company's position in the radiopharma market.

Investors sue Corcept Therapeutics, claiming the company hid FDA warnings about its key drug, relacorilant, before a 50% stock price collapse.

With a key gene therapy approval imminent and major clinical data on deck, REGENXBIO's upcoming financial report will be a crucial test for the biotech.

Flush with cash and nearing major clinical milestones for its neuromuscular disease pipeline, Dyne Therapeutics is set to make its case to investors.

With an $11.75M boost, a new device promises blood results in minutes, not hours, signaling a major pharma player's strategic pivot into diagnostics.

Insurance giant Kuvare Holdings fires back at inaccurate reports, clarifying its independent oversight in a complex asset management deal with Blue Owl.

Japan becomes the first nation outside Israel to approve Alpha DaRT, a highly precise therapy for untreatable head and neck cancers. Here’s what it means.

New FDA-cleared Persona PLUS technology promises to increase plasma yields per donor, tackling the growing global demand for life-saving therapies.

Promising trial data for onvansertib offers new hope for colorectal cancer patients, yet leadership changes and financial hurdles cloud the path forward.

The biotech firm secures major funding to push its promising head and neck cancer drug, ficerafusp alfa, toward regulatory approval and commercial launch.

After a major trial miss sent its stock tumbling, GRAIL will face investors to pitch its vision for the future of early cancer detection technology.

A newly identified blood biomarker for the drug masitinib could revolutionize how doctors treat ALS, progressive MS, and Alzheimer's disease.

A landmark study confirms a minimally invasive radiofrequency device is highly effective for chronic rhinitis, offering lasting relief beyond traditional sprays.