Shilpa Medicare receives initial authorization for Rivaroxaban Orodispersible films from EMA

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product

CHMP recommends conditional marketing authorization for Spesolimab for generalized pustular psoriasis flares

CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in

Bayer showcases cancer study data at ESMO Congress 2022

On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors

LYNPARZA approved in the EU as adjuvant treatment for early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

Vaxzevria approved in the EU as third dose booster against Covid-19

Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU

Govt. to allow 100% doses of imported and ready to use foreign vaccine

Proactively engaging with foreign vaccine manufacturers like Moderna, Pfizer etc., to apply for Emergency Use Authorization in India so that these vaccines can be easily imported and made available in India