Supernus: New Approval Holds Promise Of Increased Growth
FDA approval for ONAPGO in Parkinson's Disease offers optimism despite past challenges, with a planned Q2 launch. Read more ...
FDA approves Symbravo for acute treatment of migraine in adults
The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...
FDA approves Susvimo for diabetic macular edema
The U.S. Food and Drug Administration has approved Genentech's Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular ...
Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus
The FDA’s approval for expanded use reinforces LP-310’s potential as a new therapeutic option for OLP and supports ongoing clinical development efforts.
News Medical17h
AI predicts effective treatment for rare disease using existing medications
After combing through 4,000 existing medications, an artificial intelligence tool helped uncover one that saved the life of a patient with idiopathic multicentric Castleman's disease (iMCD).
Acrivon Therapeutics Gets FDA Breakthrough Device Designation for Cancer Identification
Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...
BioSpace1d
Supernus Taps Potential $300M US Opportunity With FDA Win for Parkinson’s Drug-Device Combo
The FDA on Tuesday signed off on Supernus Pharmaceuticals’ apomorphine hydrochloride injection—to be marketed under the brand ...
Newronika Receives Investigational Device Exemption (IDE) from FDA to Initiate U.S. Clinical Trial of Adaptive DBS System
Newronika, the developer of groundbreaking adaptive deep brain stimulation technology, is proud to announce the receipt of an Investigational Device Exemption ...
The American Journal of Managed Care3d
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 ...
Rutgers University3d
Common Treatment for Binge Eating Disorder Shows Mixed Results
Patients taking a commonly used stimulant for the treatment of binge eating disorder experienced mixed results, according to ...
Alpha Tau announces FDA approval of IDE supplement
Medical announced an approval from the U.S. Food and Drug Administration, FDA, of an Investigational Device Exemption IDE, ...
Vertex Pharmaceuticals Just Won a Huge FDA Approval. Is the Biotech Stock a No-Brainer Buy?
Vertex Pharmaceuticals (NASDAQ: VRTX) 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 ...