News

Articles

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

FDA Publishes Draft Guidance on Quality Assessments

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

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.

Kapruvia Approved by EC for Treatment of Pruritus

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

Industry News