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GSK has received a positive recommendation from the EMA’s CHMP for Nucala (mepolizumab) to be used as a treatment in three additional eosinophil-driven diseases.

GSK Receives Positive Opinion from CHMP for Nucala

Celltrion Group has been granted approval for regdanvimab (CT-P59) to be used as a treatment for COVID-19 by the Korean Ministry of Food and Drug Safety (MFDS). 

Celltrion Gains Regulatory Nod in Korea for Regdanvimab

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA. 

FDA Grants Accelerated Approval for Recurrent or Metastatic Cervical Cancer Treatment to Tivdak

Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.

Verrica's Molluscum Treatment Rejected by FDA Following CMO Facility Deficiencies

US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.

Federal Court Enters Consent Decree Against Florida Compounder

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

FDA Approves Biosimilar for Treatment of Eye Disease

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

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Vaccine Booster Battle Reveals Rifts Among Regulators and Sponsors

Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.

Health Canada Approves Moderna’s COVID-19 Vaccine, Spikevax, for 12 Years & Up

FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.

FDA Revises EUA for Use of Bamlanivimab and Etesevimab for Post-Exposure Prophylaxis Prevention for COVID-19

Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.

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