(RTTNews) - Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) and the European Medicines ...
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 ...
Elicio Therapeutics received FDA feedback supporting ELI-002's Phase 3 study design; Phase 2 analysis results expected in H1 2025. Elicio Therapeutics announced positive feedback from the FDA ...
(RTTNews) - Eli Lilly and Co. (LLY) announced that the U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in ...
(RTTNews) - AstraZeneca (AZN), on Friday, announced that the FDA has approved CALQUENCE in combination with bendamustine and rituximab for the first-line treatment of adult patients with ...
FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
(RTTNews) - The U.S. Food and Drug Administration approved AstraZeneca (AZN, AZN.L) and Daiichi Sankyo's (DSKYF.PK) Datroway (datopotamab deruxtecan-dlnk) for the treatment of adult patients with ...
BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's ...
(RTTNews) - 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 novel drugs, matching the total from 2021 and making ...
ANI Pharmaceuticals, Inc. announced the launch of its Prucalopride Tablets, a generic version of the drug Motegrity®, following final FDA approval of their Abbreviated New Drug Application.
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.
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 ...
Johnson & Johnson JNJ announced that the FDA has accepted its regulatory filing seeking the FDA’s approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in ...
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