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3817 News Found

Thermo Fisher receives AIFA’s GMP approval for manufacturing facility of RNA-based products in Italy
News | January 22, 2024

Thermo Fisher receives AIFA’s GMP approval for manufacturing facility of RNA-based products in Italy

GMP certification helps enable biotechnology customers to accelerate accessibility of new RNA-based therapies for patients


Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg
Drug Approval | January 20, 2024

Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg

This product has sales of about US$ 20 million in Europe


Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market
Drug Approval | January 19, 2024

Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market

Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets


Lupin receives USFDA’s approval for Febuxostat Tablets
Drug Approval | January 19, 2024

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)


Indoco Remedies receives EIR from USFDA for Goa Plant-I
Drug Approval | January 18, 2024

Indoco Remedies receives EIR from USFDA for Goa Plant-I

The PAI was conducted for two drug product applications (ANDAs) filed from this facility


Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg
Drug Approval | January 18, 2024

Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis


Tritan used for safer medical infusion therapy
Medical Device | January 17, 2024

Tritan used for safer medical infusion therapy

This turn valve is considered revolutionary because it supports back-to-back drug infusion through the same device


Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India
News | January 17, 2024

Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India

Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa


CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'
News | January 17, 2024

CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'

Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer