Articles

The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.

FDA Launches Accelerated Rare Disease Cures Program

908 Devices and CPI have formed a collaboration to optimize cell culture media to allow for improved process control.

908 Devices and CPI Partner to Optimize Cell Culture Media for Improved Process Control

Lonza and Integral Molecular will collaborate to better assess the risks of off-target binding of biologic drug candidates.

Lonza and Integral Molecular Enter Biotherapeutics De-Risking Collaboration

MilliporeSigma’s ZooMAb antibodies have been recognized for their low environmental impact by My Green Lab.

MilliporeSigma’s ZooMAb Antibodies Earn ACT Label from My Green Lab

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

FDA Limits Use of Janssen COVID-19 Vaccine

 Washington Editor, jillwechsler7@gmail.com.

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.

Escalating Abortion Battle Threatens FDA Authority

AstraZeneca has announced plans to open a new strategic R&D center in Cambridge, MA, which will also serve as Alexion’s headquarters.

AstraZeneca Announces Plans for New Strategic R&D Center

Janssen has submitted a marketing authorization application to EMA for the approval of a treatment for patients with HRR gene-mutated metastatic castration-resistant prostate cancer.

Janssen Submits Marketing Authorization Application for Treatment of Metastatic Castration-Resistant Prostate Cancer

Purolite has received the Queen’s Award for Enterprise in the International Trade category.

Purolite Awarded Queen’s Award for Enterprise

Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.

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