Shilpa Medicare receives UK MHRA approval for mouth-dissolving strips to treat illnesses

This approval has come from the company's finished dosage form manufacturing facility

Pfizer and BioNTech receive positive CHMP opinion for Omicron XBB.1.5-adapted COVID-19 vaccine

The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older

EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema

LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease

Merck receives positive European Union CHMP opinion for Gefapixant

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU

Dupixent is now approved in India for the treatment of adults with moderate-to-severe atopic dermatitis

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia

Rystiggo needs marketing strategy to fully compete in myasthenia gravis space, says GlobalData

Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024