Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive ...
(RTTNews) - Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the ... do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s ...
Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the national launch of the company’s FDA-approved, NGS-based ...
(RTTNews) - AstraZeneca (AZN), on Friday, announced that the FDA has approved CALQUENCE in ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
Received supportive FDA feedback on key elements of the potential ... Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company ...
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB), a commercial-stage biopharmaceutical company with a "GOOD" InvestingPro Financial ...
In 2024, the FDA approved 50 novel drugs ... views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
We recently published a list of 10 Unstoppable Stocks to Buy in 2025. In this article, we are going to take a look at where ...
(Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has launched Prucalopride ...
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...
The FDA granted priority review designation to J&J’s biologics license application (BLA) seeking approval of nipocalimab for antibody-positive patients with gMG, a rare, autoantibody-driven disease.