Bipartisan draft legislation was presented by the Senate Committee on Health, Education, Labor and Pensions (HELP) and chairman Lamar Alexander (R-TN) and Patty Murray (D-WA) that includes proposals featuring the use of biosimilars to lower health care costs.
Zolgensma, a gene therapy to treat spinal muscular atrophy (SMA) in infants, will be the world’s most expensive drug at $2.1 million.
SurgicalAR™ Officially Brings Holographic Visualization into the Operating Room
Rykindo® (LY03004), Luye Pharma's innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S. market.
On-Demand Same-Day Extragenital Testing for Chlamydia and Gonorrhea Fills Critical Unmet Need in Fight Against Rising Rates of Chlamydial and Gonorrheal Infection
Leica Biosystems, the global leader in pathology workflow solutions, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aperio AT2 DX System for clinical diagnosis in the U.S.
WASHINGTON -- The New York Times recently published a lengthy story about stem cell treatments, describing the Food and Drug Administration’s approach as industry friendly.
The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.
North Carolina passed a Right to Try law back in 2015 yet a bill introduced in April could expand that stem cell treatment law.
How much is too much when it comes to the price of prescription drugs? This week, U.S. Senators John Cornyn (R-Texas) and Richard Blumenthal (D-Connecticut) crossed party lines and introduced a bill to answer that very question.
Accelerated pathway for companion diagnostic development granted to cell-free DNA assay for detecting HRD mutations and gene deletions
NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to fulfill unmet medical needs in treating difficult and life-threatening viral diseases, reports that it has received favorable comments from the US FDA on the Company's pre-IND application for its lead drug candidate.
Medical Marijuana, Inc. (OTC: MJNA) (the "Company"), the first-ever publicly traded cannabis company in the United Statesthat launched the world's first-ever cannabis-derived nutraceutical products, brands and supply chain, announced today that Dr. Stuart Titus, the Company's Chief Executive Officer, was featured in several national and international news publications about his speaking engagement at the U.S. Food and Drug Administration (FDA) Hearing on cannabis and cannabidiol (CBD) on Friday, May 31, 2019.
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Data from the Gore ASSURED Clinical Study demonstrated 100 percent closure success at six months
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U.S. District Judge Ursula Ungaro of the Southern District of Florida granted the government’s motion for summary judgment against US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D.
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Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF).
The FDA Drug Approval Process conference in London will provide an overview of procedures and requirements for the U.S. drug approval process.
R3 Stem Cell and CEO David Green received an untitled letter from the Food and Drug Administration (FDA) for unapproved stem cell products offered at its more than 50 centers around the U.S.
FDA clearance is part of Company's three-part strategy to change the business paradigm for the molecular diagnostic industry
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R3 Stem Cell, LLC (R3), a leader in regenerative therapy practices, issued a formal response to a letter it received from the FDA that raised concerns over alleged unapproved stem cell products to treat a variety of diseases and conditions as well as potential safety concerns.