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2469 News Found

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA
News | February 03, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia


Cupid gets female condom variant UNFPA prequalified to supply 100% of upcoming South Africa tender
News | January 25, 2025

Cupid gets female condom variant UNFPA prequalified to supply 100% of upcoming South Africa tender

Earlier, Cupid Limited had been eligible to supply 75% of the contract for female condoms in previous tenders


Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary
News | January 07, 2025

Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary

These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route


Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria
News | December 22, 2024

Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria

The company has received the GMP Certification after successful closure of the inspection


Lupin acquires 3 Trademarks from Boehringer Ingelheim for diabetes portfolio
News | December 14, 2024

Lupin acquires 3 Trademarks from Boehringer Ingelheim for diabetes portfolio

The trademark rights for these brands will be transferred to Lupin by March next year.


Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium
Diagnostic Center | December 11, 2024

Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium

Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity (clinical benefit rate


EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility
Drug Approval | November 13, 2024

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections


Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years
News | October 19, 2024

Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years

Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years


Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
Drug Approval | September 23, 2024

Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA


EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
News | August 19, 2024

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile