Tag
FDA
- Natera receives FDA breakthrough designation for multi-cancer blood test
- Ultragenyx Pharmaceutical agrees to sell rare pediatric voucher for US$210M
- Rezolute says FDA recommends pre‑BLA meeting after congenital HI trial miss
- HeartBeam receives FDA breakthrough status for heart attack assessment
- Stoke Therapeutics details Dravet cognition analysis after FDA meeting
- Vaxcyte reports VAX‑31 met all OPUS‑1 primary immune endpoints
- Alvotech gains FDA approval for second SIMLANDI production suite
- Novo Nordisk A/S says FDA extends denecimig review over facility remediation
- Cullinan Therapeutics begins FDA submission for zipalertinib combination
- Wave Life Sciences plans two‑year WVE‑006 trial after FDA feedback
- United Therapeutics Corporation wins Yutrepia PH‑ILD patent ruling
- Immunome gains FDA IND clearance for IM‑1340 solid tumour study
- Takeda details 36.5% complete clearance versus Sotyktu in Phase 3
- DBV Technologies submits peanut patch BLA for children aged 4 to 7
- Unicycive Therapeutics resubmits oxylanthanum carbonate NDA to FDA
- Merck and Daiichi Sankyo withdraw ifinatamab deruxtecan BLA
- aTyr Pharma says FDA aligned on 372‑patient sarcoidosis trial
- Mesoblast gets FDA approval for new Ryoncil potency assay
- Definium Therapeutics reports 5.1‑point gap in second Phase 3 anxiety study
- GRAIL jumps 34% as FDA staff raise no major concerns on Galleri cancer test
- FDA psychedelics hearing draws little pushback on future therapeutic use
- Replimune tanks on FDA concerns about its skin cancer therapy
- Four tech startups turning to Regulation Crowdfunding: A Mugglehead roundup
- FDA issues recall notice for Tandem Mobi insulin pumps over concerning software glitch
- Medtronic spin‑out MiniMed lists on Nasdaq, attains EU approval for diabetes tech
- Optellum breaks new ground with TGA approval for AI‑powered lung nodule solution
- Tempus AI builds on FDA win with Median partnership for lung cancer detection
- New Jersey hops on the medical psilocybin therapy train
- Lung Cancer Research Foundation expands 2025 grant program
- Maryland task force says natural psychedelics are safe for therapeutic purposes
- Researchers to start FDA‑approved study on ‘Jedi Mind Fuck’ psilocybin
- California governor signs bill to promote state psychedelics research
- McMaster surgeon develops AI tool to reduce invasive lung biopsies
- Inovio advances DNA medicine for debilitating respiratory condition
- Eight Sleep raises US$100M to propel its AI‑integrated mattress technology
- AI‑integrated toothbrushes are a thing now
- Luxury hotel in Singapore starts using 'DeepSleep' sound tech from NuCalm
- Whoop on the FDA hot seat for not following marketing rules
- Johnson & Johnson subsidiary sued for USD$147M for breaching antitrust rules in California
- Onc.AI's lung cancer analysis tool gets FDA Breakthrough Device Designation
- FDA gives Zai Lab's small cell lung cancer therapeutic orphan drug designation
- Sagimet Biosciences up 30% on strong clinical stage data
- Neurogene patient dies in drug trial, stock surges after FDA says 'use lower dose'
- FDA gives long-awaited green light to veterans cannabis trial for PTSD
- Breath Diagnostics onboards new president and closes critical financing
- MIRA Pharma up 27% on ketamine analogue's preclinical results for chemotherapy pain
- Novocure scoops FDA approval for electric field lung cancer treatment device
- Vivos Therapeutics surges on FDA approval for youth sleep apnea treatment device
- Breath Diagnostics takes aim at lung cancer with One Breath
- Investors wince as FDA panel rejects proposal to approve 'molly' for PTSD therapy