Quality Systems

Articles

Verquvo is a soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure. 

FDA Approves Merck’s Symptomatic Heart Failure Drug

The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.

AstraZeneca and Daiichi Sankyo’s Breast Cancer Treatment Approved for Use in Europe

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA puts applications on hold as the agency limits alternative oversight methods. 

FDA Inspection Shutdown Increasingly Delays Approvals

The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

Despite Pandemic, FDA Ramps Up New Drug Approvals

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

FDA approval rate speeds up despite COVID-19 complications.

FDA Ends 2020 with High Drug Approval Rate

Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.

Oxford/AstraZeneca Vaccine Granted Emergency Use Approval in UK

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation. 

Second COVID-19 Vaccine Granted EUA, Ships for Immediate Use

The guidance provides information on review timelines during the COVID-19 pandemic.

FDA Publishes Guidance on CRLs Response Timelines during Pandemic

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

FDA Approves First-of-its-Kind Genomically Altered Line of Pigs for Potential Therapeutic Uses

Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).

Regulatory Filings and Submissions