EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process

AstraZeneca’s Imfinzi combination shows positive results in phase 3 liver cancer study

About 75% of all primary liver cancers in adults are HCC and up to 30% of HCC patients are eligible for embolisation

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy

European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer

TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union

Eugia Pharma Specialities receives USFDA final approval for Posaconazole Injection

The product is expected to be launched in December 2023

Zydus receives final USFDA approval for Cyclophosphamide Capsules USP, 25 mg and 50 mg

Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell

Venus Remedies gets marketing approvals from Philippines, Saudi Arabia for three drugs

Venus Remedies is supplying the drug to many countries like Colombia, Thailand, Tanzania, Morocco, Myanmar, Indonesia, Saudi Arabia, Malaysia, Zimbabwe, Sri Lanka, Pakistan, Kenya, and Botswana

DxVx plans to make a license-in agreement of OVM-200

Final stage in licensing OVM-200 from Oxford Vacmedix in the UK

Evive Biotech and Acrotech Biopharma receive FDA approval of Ryzneuta