Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA

Shots: The US FDA and the EMA has accepted Teva’s applications for TVB-009P, biosimilar version of Prolia (denosumab), for all the approved indications, with their decisions anticipated during H2’25 Submissions were built upon the data from P-III (TVB009-IMB-30085) study assessing safety & efficacy of TVB-009P vs Prolia among women with postmenopausal osteoporosis as well as…

ByDipanshu DixitOctober 8, 2024

NEWS

Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications

Shots: Teva Pharmaceuticals and mAbxience have signed a strategic licensing agreement across various markets incl. the EU and the US to develop a biosimilar product that is under development as a treatment for various oncology indications As per the agreement, mAbxience will develop and produce the candidates by utilizing the knowledge of biosimilar development &…

ByDipanshu DixitApril 4, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2023

Shots:The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 19 novel products in 2023In February 2023, the major highlights drugs were, Tezspire (tezepelumab) approval for severe asthma, Altuviiio for hemophilia APharmaShots has compiled…

BySenior EditorMarch 15, 2023

Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA

Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications

Insights+: The US FDA New Drug Approvals in February 2023

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