April 26, 2024
There are two regulatory pathways to bring a nonprescription drug to market in the U.S. — the drug application process and Over-the-Counter (OTC) Drug Review (OTC […]
April 26, 2024
1999-2003 BLA information is available in the FDA Archive The therapeutic biological products include: Monoclonal antibodies for in-vivo use Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics […]
April 26, 2024
The European Medicines Agency (EMA) this week recommended granting a marketing authorization for Altuvoct (efanesoctocog alfa) for the treatment and prophylaxis of bleeding in patients with hemophilia […]
April 26, 2024
FDA aspires to continually improve its pre-ANDA (abbreviated new drug application) interactions with applicants. To facilitate these interactions and keep stakeholders as informed as possible, the […]
April 26, 2024
CDER researchers have conducted a randomized study to better understand how physicians make prescribing decisions. As they make decisions about which drug products should be prescribed […]
April 26, 2024
On This Page Date: June 6, 2024 Time: 9:30 AM – 10:40 AM ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]
April 26, 2024
A marketing authorization should be given for the medicinal product Obgemsa (vibegron) for treating adults with overactive bladder (OAB) syndrome, the European Medicines Agency (EMA) has […]
April 26, 2024
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) this week recommended new contraindications on the coadministration of the protease […]
April 26, 2024
At an April 25 meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended marketing authorization for two biosimilar medicines: Tofidence, […]
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