Tivic Health targets FDA approval for Entolimod within 18 months, highlights transformation into biopharma
The company also anticipates opportunities for emergency use authorization in international markets before FDA approval. Tivic expects to leverage Entolimod for additional indications, including ...
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Alnylam drug wins FDA approval for progressive heart disease
Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce ...
Clearmind Medicine’s FDA-Approved Clinical Trial for CMND-100 Moves Forward as Drug Arrives in the U.S., Advancing Toward Key Milestones
CMND-100, a proprietary MEAI-based oral drug candidate, represents a potential breakthrough in AUD treatment, targeting the reduction of alcohol consumption and cravings through a novel mechanism of ...
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Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...
Alnylam's Amvuttra Gets Approval for Expanded Indication From FDA
Alnylam Pharmaceuticals' amyloidosis drug Amvuttra received Food and Drug Administration approval for an expanded indication.
Jumping Into The FDA Gamble: Initiating Hims & Hers With A Buy
Hims & Hers Health, Inc. stock faces volatility after an FDA halt on its GLP-1 drug. Click here to find out why HIMS stock is ...
LENZ Therapeutics, Inc.: LENZ Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights
New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025 Upon FDA approval, commercial launch activities to commence immediately with ...
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Perimeter Files FDA PMA Application for its Next-Generation B-Series OCT with ImgAssist AI 2.0
Information on the FDA review process for PMA applications can be found on the FDA website at: https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process. There can be no assurance ...
Is green beer bad for you? What to know about the dye that makes the St. Paddy's tradition
Here's when St. Patrick's Day 2025 is, the origin of the holiday and what to know about the food dye that colors the holiday's trademark green beer.
InspireMD Reports Fourth Quarter and Full Year 2024 Financial Results
(Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced financial and operating results for the fourth ...
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Trump’s FDA nominee faces Senate questions after agency layoffs and resignations
including telehealth and drug companies that sell compounded versions of FDA-approved drugs. The Associated Press Health and Science Department receives support from the Howard Hughes Medical ...
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FDA Drug Approval Decisions Expected in April 2025
The FDA is expected to decide on treatments for ... The Company is seeking approval for acute treatment of migraine with or without aura.