In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. | GSK had expected to secure an FDA ...

The US Food and Drug Administration has approved three new color additives from natural sources “that will expand the palette ...

Food and Drug Administration Commissioner Marty Makary, M.D., spoke about the need to shorten the length of the drug approval ...

A recent FDA alert warned of lasting ... the time off-label—use a product that is not specifically studied for, and that’s OK. But it does mean that topical finasteride has not undergone ...

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn ... There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause ...

Companies applying for approval of ... might have on the FDA’s effectiveness. “There's a lot of people with impressive sounding titles, but that may not necessarily mean that they are working ...

What Does Guaranteed Approval Mean? Guaranteed approval refers to a ... impact borrowers' ability to repay the loans, and if not managed properly, can lead to a cycle of debt.

Bristol-Myers Squibb's has become the first company to bring a cardiac myosin inhibitor through to FDA ... not treated effectively, it can lead to atrial fibrillation, stroke, and heart failure ...

In the end, the FDA took little more than six weeks ... though its CAR-T treatment is not far behind, looking set for approval in November. Novartis has already declared that a one-time treatment ...

ANKTIVA was approved by the FDA in 2024 with BCG for the treatment ... The RTF letter referenced herein does not impact this prior approval of CIS +/- Papillary in BCG unresponsive patients.

NMN supplements are not FDA-approved to treat or prevent disease ... individuals with specific medical contraindications without medical supervision. How Long Does It Take to See Results? Results can ...