You are here: Industry Insights > FDA

News List

Weekly Pharma News Review | PharmaSources.com （April.18th - 22ed） PharmaSources.com
April 27, 2022
The pharma news review of this week totally covers 22 pieces of news in 3 sections, including drug review, R&D, and business.
Updates on the Bioequivalence Studies for Drugs Submitted to Under an ANDA Lin Zhang
April 08, 2022
From time to time, the Food and Drug Administration (FDA) offers a lot of updates to its materials and practices, and any person involved with the industry needs to stay alert for new releases, educational events, and training.
A Brief Overview of the FDA Bioresearch Monitoring (BIMO) Program Lin Zhang
April 08, 2022
The U.S. Food and Drug Administration (FDA) held a webinar on the Bioresearch Monitoring program (BIMO) last month (2/16/2022).
Going Global Successfully! BCMA CAR-T of Legend Biotech is Approved by FDA for Marketing! PharmaSources/Small pill
March 16, 2022
On February 28 local time, LEGN.US officially announced in Somerset, New Jersey, U.S., that its self-developed BCMA-targeted CAR-T therapy, ciltacabtagene autoleucel (trade name: CARVYKTI®), abbreviated as Cilta-cel, was approved for marketing by the FDA.
FDA new regulation: Improving pharma product security through serialization and track & trace Muhammad Asim Niazi
March 01, 2022
The FDA in the United States is the regulator for Pharmaceutical drugs and plays various roles in the human health field. Among them, the most critical is the safety of pharma products.
The Impact of the Regulatory Science Summit 2022 Lin Zhang
February 28, 2022
The UCSF-Stanford Center of Excellence in Regulatory Science Innovation or CERSI is known for offering yearly summits focused on academia, biomedical industry, and regulatory affairs.
Boost for Dry Eye Disease Treatment As FDA Approves Generic Drug SHEM OIRERE
February 28, 2022
The Federal Drugs Agency (FDA) has approved the Abbreviated New Drug Application for the making of Cyclo-sporine Ophthalmic Emulsion 0.05%, the first generic version of AbbVie Inc's Re-stasis. (1)
Fighting Against COVID-19: Summary of Key Products PharmaSources/Recollect
February 22, 2022
Since the outbreak of COVID-19 in 2019, many kinds of COVID-19 vaccines, COVID-19 preventive drugs and COVID-19 therapeutic drugs have been approved worldwide.
AbbVie's performance in 2021: a new high in total revenue, with the sales volumes of Hu-mi-ra topping USD 20 billion PharmaSources/Yi
February 22, 2022
On February 2, AbbVie announced its performance in the fourth quarter and full year of 2021, representing an annual revenue of USD 56.197 billion (+22.7%) and R&D investment of USD 7.084 billion (+8%).
An Introduction to FDA Clinical Investigator Training Course Lin Zhang
January 17, 2022
The U.S. Food and Drug Administration (FDA) held a Clinical Investigator Training Course or the CITC last month (12/7-8/2021). This course has been conducted for over ten years.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 365 366 Next page