The Latest Breaking News from FDA

Innate Pharma Q1 Earnings Call Highlights

Innate Pharma (NASDAQ:IPHA) said its first-quarter 2026 business update centered on three priority clinical assets: lacutamab in cutaneous T-cell lymphoma, the Nectin-4 antibody-drug conjugate IPH4502 in advanced solid tumors, and the AstraZeneca-partnered monalizumab program in non-small cell lung

MarketBeat · May 13

FDA chief's resignation widens a leadership gap at the nation's health department

Dr. Marty Makary's resignation from his post atop the Food and Drug Administration is widening a leadership gap that already existed at the U.S. Department of Health and Human Services

The Independent UK · May 13

Brainsway Q1 Earnings Call Highlights

Brainsway (NASDAQ:BWAY) reported a strong start to 2026, with first-quarter revenue rising 35% year over year as the company expanded placements of its Deep TMS systems and continued to build its recurring revenue base. Chief Executive Officer Hadar Levy said on the company’s earnings call that rev

MarketBeat · May 13

What Is Kratom? Substance Linked To Brandon Clarke Arrest Draws Attention

The death of Brandon Clarke has intensified scrutiny on kratom, a controversial plant-based substance linked to health risks & legal debates in the US

International Business Times UK · May 13

Makary's exit creates new uncertainty at FDA

His departure won't solve the organizational upheaval and political jockeying that marked much of his tenure.

Axios · May 13

Caris Life Sciences Eyes Bigger Oncology Market After IPO as Revenue Jumps 79%

Caris Life Sciences (NASDAQ:CAI) executives said the company is expanding its commercial reach, product pipeline and biopharma partnerships as it looks to build on recent revenue growth following its IPO last June. Speaking at an investor conference, a Caris executive identified by Chief Scientific

MarketBeat · May 13

Novo Nordisk A/S Q1 Earnings Call Highlights

Novo Nordisk A/S (NYSE:NVO) said its first quarter of 2026 was marked by rapid uptake of its newly launched Wegovy pill in the U.S., continued expansion of its obesity franchise and a series of pipeline and regulatory milestones, even as adjusted sales declined because of lower realized prices. Chi

MarketBeat · May 13

TriSalus Life Sciences Q1 Earnings Call Highlights

TriSalus Life Sciences (NASDAQ:TLSI) reported slightly lower first-quarter revenue and reduced its full-year 2026 revenue outlook, citing disruption from a broad commercial reorganization and a delayed FDA review for its next-generation TriNav Advance device. President and Chief Executive Officer M

MarketBeat · May 13

NeuroPace Q1 Earnings Call Highlights

NeuroPace (NASDAQ:NPCE) raised its 2026 revenue outlook after reporting first-quarter results that management said reflected continued demand for its RNS System and improving commercial execution across epilepsy treatment centers. The company reported total revenue of $22.1 million for the first qu

MarketBeat · May 13

Spectral AI Q1 Earnings Call Highlights

Spectral AI (NASDAQ:MDAI) said it remains on track toward potential U.S. regulatory clearance and commercialization of its DeepView system for burn assessment, while reporting lower first-quarter research and development revenue tied to the completion of work under a federal contract. On the compan

MarketBeat · May 13