March 7, 2024
The US Food and Drug Administration (FDA) has approved the biosimilar tocilizumab-aazg (Tyenne), Fresenius Kabi, the drug’s manufacturer, announced today. This is the second tocilizumab biosimilar […]
March 7, 2024
FDA’s Drug Supply Chain Security Act (DSCSA) Pilot Project Program was established to assist drug supply chain stakeholders, including FDA, with developing electronic, interoperable capabilities that […]
March 7, 2024
On March 6, 2024, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult […]
March 7, 2024
Reports Mandated by FDORA The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents, including public […]
March 7, 2024
UPDATE: On March 20, 2023, the FDA announced the withdrawal (revocation) of the biologics license for BLENREP indicated for the treatment of adult patients with relapsed or […]
March 7, 2024
The prevailing view of menopause as an endocrine deficiency has led to a “disease-based model” that leads to over-medicalisation of this inevitable life transition, according to […]
March 7, 2024
WEST PALM BEACH, Fla. — Patient-reported outcomes (PROs) define the issues that matter to the patient, but their potential in multiple sclerosis (MS) is likely to […]
March 7, 2024
TOPLINE: The odds of having cognitive impairment may be increased among children with atopic dermatitis (AD), primarily among those with neurodevelopmental disorders, such as attention-deficit/hyperactivity disorder […]
March 7, 2024
Criteria to Participate in the Emerging Technology Program To qualify for participation in the Emerging Technology Program, technologies need to: Have the potential to improve product […]
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