SpringWorks Therapeutics sets wholesale acquisition cost for GOMEKLI at $206.25
SpringWorks Therapeutics (SWTX) has announced that the U.S. Food and Drug Administration has approved GOMEKLI, a small molecule MEK inhibitor, ...
Implantica announces Module 1 is accepted and closed by FDA in the PMA application for RefluxStop
Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop ...
Implantica announces Module 1 is accepted and closed by FDA in the PMA application for RefluxStop™
Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique ...
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
Business Wire2d
LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has ac ...
News Medical2d
Ariceum Therapeutics receives FDA’s Orphan Drug Designation for targeted radionuclide cancer treatment
Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food ...
Experts: Journavx a prescription to stem Long Island's addiction crisis
Now a third option is available after the U.S. Food and Drug Administration last week approved Vertex Pharmaceuticals’ ...
The American Journal of Managed Care9d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Vertex Pharmaceuticals Just Won a Huge FDA Approval. Is the Biotech Stock a No-Brainer Buy?
Vertex Pharmaceuticals ( VRTX 5.31%) just snagged its second U.S. Food and Drug Administration (FDA) approval in only 41 days. On Dec. 20, 2024, the FDA gave a thumbs-up to Alyftrek in treating cystic ...
News Medical11d
Key information to consider before getting breast implants
Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery?
Vertex Pharmaceuticals' non-opioid pain medication gets FDA approval
A non-opioid pain medication made by Vertex Pharmaceuticals has received approval for adults from the Food and Drug ...