The US Food and Drug Administration (FDA) has granted pre-market approval (510K) to HLB Life Science’s Sofject disposable ...

The FDA is expected to decide on treatments for Parkinson disease, PTSD and NF1-associated plexiform neurofibromas, in addition to 2 new vaccines.

maintaining FDA's guardrails and oversight, and the normal approval process." Notably, all the information shared during pre-approval from a manufacturer with a payer will be marked with a ...

Neffy for severe allergic reactions and Dupixent for chronic obstructive pulmonary disease (COPD), which all gained FDA approval this year. These medications are "slated to make a big clinical ...

In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, ...

As we enter the new year, all eyes are on the biotech companies awaiting key FDA decisions in January. In 2024, the FDA approved 50 ...

The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...

Let FDA approve NPIs While I have grave concerns about regulatory capture during the drugs approvals process at the Federal ...

The U.S. Food and Drug Administration (FDA) has approved a generic daily injectable for the GLP-1 medication for patients who ...

In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies ...

risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical ...