On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...

Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...

Agios Pharmaceuticals, Inc. (AGIO), on Wednesday, announced that its supplemental New Drug Application seeking approval for the ...

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

Independence Blue Cross has begun excluding coverage for 18 months for therapies — but not cancer drugs — that have an ...

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, ...

Specifically, devices that are approved through a process that does not require any clinical evidence for FDA authorization should not automatically meet Medicare coverage criteria, which ...

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 ...

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 ...

Previously, RevBio received FDA approval to initiate a first-in-human ... important step in the overall product commercialization process.” About RevBio, Inc. RevBio, Inc., is a clinical stage ...