Guardant Health Leads the Way in Blood-Based Single Cancer Screening
As of December 2024, Guardant held $840 million of cash and marketable securities. However, it burned through approximately $390 million in 2022, $345 million in 2023, and $275 million in 2024.
FDA declares Wegovy® and Ozempic® shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses
Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has determined the shortage of Wegovy® and Ozempic® is resolved. The FDA's assessment confirms the U.S. supply of these ...
Neurology Advisor37m
FDA Approves Tablet Form of Evrysdi for Spinal Muscular Atrophy
The US Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA).
JD Supra50m
FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many ...
infectiousdiseaseadvisor.com1h
FDA Approves Vimkunya to Protect Against Chikungunya Virus
Vimkunya is supplied as an injectable suspension; the vaccine is administered intramuscularly as a single 0.8 mL dose.
With RFK Jr. in charge, supplement makers see chance to cash in
The FDA is already limited in policing claims of health benefits by makers of supplements and herbal remedies — a $70 billion ...
Eli Lilly (LLY) Stockpiles Weight Loss Pill Ahead of Regulatory Approval
Eli Lilly’s (LLY) new weight loss pill is still in clinical trials and has not yet been approved by regulators. But that hasn ...
OnePlus seeks FDA approval for Sleep Apnea Detection on its watch and takes on Apple in the process
OnePlus is hoping the OnePlus Watch 3 could get FDA approval for its new sleep apnea detection feature, bringing it one step ...
JD Supra20h
FDA Approved Journavx, a Non-Opioid Drug for Pain Management
On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid ...
Medscape20h
Dupilumab Under FDA Priority Review for Bullous Pemphigoid
Patients treated with on dupilumab showed significant improvement in sustained BP remission compared with those on placebo.
Ionis Continues to Expand Its Cardiology and Neurology Portfolio, Supporting Narrow Moat
Ionis relies on upfront payments and licensing fees from partners, as well as Spinraza royalties, to drive revenue today, but its rapidly advancing portfolio should help diversify revenue. 2025 is ...
News Medical1d
Vimseltinib gains FDA approval for treating tenosynovial giant cell tumor
The U.S. Food and Drug Administration (FDA) has approved vimseltinib (RomvimzaTM) for adult patients with a rare condition called tenosynovial giant cell tumor (TGCT). TGCT is a tumor of the tissue ...