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 ...
(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 ...
FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
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 ...
Scholar Rock submitted its BLA of apitegromab for the treatment of patients with Spinal Muscular Atrophy with a request for Priority Review to be given. Explore more details here.
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 ...
(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 ...
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 ...
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.
The FDA spokesperson indicated that the policy could ... 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should ...
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