Quality Systems

Articles

The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.

EC approves GSK’s Benlysta for Adults with Active Lupus Nephritis

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

EC Approves Additional Indication for Roche’s Tecentriq in Lung Cancer Treatment

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Sandoz Begins Late-Stage Clinical Development for Biosimilar Aflibercept

Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.

Janssen Seeks European Approval of BCMA CAR-T Therapy

FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

Merck’s Keytruda Approved in Combination with Trastuzumab and Chemotherapy for Cancer Treatment

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

GSK Gets EC and FDA Approval for Endometrial Cancer Biologic, Jemperli

The agency revoked EUA status for the monoclonal antibody bamlanivimab to be administered alone to treat mild-to-moderate COVID-19.

FDA Revokes Emergency Use Authorization for COVID-19 Treatment

NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

NICE Issues Positive Recommendation for Use of Kineret to Treat Still’s Disease

EMA's CHMP has issued a positive opinion for Diurnal's second product in Europe, Chronocort (Efmody), to treat CAH.

Diurnal Gains Positive Opinion for Second Product in Europe

The EC has approved Roche's treatment for 5q spinal muscular atrophy (SMA), Evrysdi (risdiplam).

Regulatory Filings and Submissions