The Latest Breaking News from FDA

A new type of blood test that checks for signs of cancer in healthy people has hit the market

A new study shows how most pet owners don't know or follow FDA food handling guidelines, which could negatively affect human and canine health.

Soon after Dr. Mai Fleming finished her medical residency in the San Francisco Bay Area, she got to work on her Texas medical license. The family medicine doctor had no intention of moving there but invested nine months to master Texas medical law, submit to background checks, get fingerprinted and…

The U.S. Medicare program’s decision to tightly limit coverage for the first drug meant to slow the course of Alzheimer’s disease has raised the stakes for companies trying to make the next one.

Medicare has decided once and for all not to pay for Biogen’s new Alzheimer’s drug Aduhelm unless patients are enrolled in a clinical study.

Needham is initiating coverage on STAAR Surgical Company (NASDAQ:STAA) with a Buy rating and an $87 price target. The analysts note that FDA approval of STAA's EVO Implantable Collamer Lens (ICLs) should serve as a meaningful tailwind for revenue. The Company generates most of its revenue from outside US markets. But after the FDA approval…

This article by Freddie Earlam was originally published on Microdose and appears here with permission. If the industry-defining research already conducted at UK centers such as Imperial College, King’s college or even Exeter University’s recent Ketamine Research isn’t enough to convince you, then two more crucial factors surely will. Firstly, a new ‘accelerated pathway’ has…

Zynex Inc (NASDAQ:ZYXI) expects Q1 FY22 sales of $30.5 million - $31.5 million, approximately 26% higher than Q1 2021, in line with the consensus of $31.04 million. Earlier, the Company had forecasted sales of $29 million - $32 million. The Company expects adjusted EBITDA between $3 million - $4 million versus the prior…

The FDA has approved Amphastar Pharmaceuticals Inc's (NASDAQ:AMPH) Abbreviated New Drug Application for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe.  Ganirelix acetate injection is indicated to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.  The FDA determined Amphastar's ganirelix is bioequivalent and therapeutically equivalent to Organon & Co's (NYSE:OGN) Ganirelix…

Reuters

Centers for Medicare and Medicaid Services (CMS) finalized its decision to restrict coverage for Biogen Inc's (NASDAQ:&