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Results For "approval"

2479 News Found

Bristol Myers Squibb appoints Cristian Massacesi as EVP, Chief Medical Officer, and Head of Development
People | July 31, 2025

Bristol Myers Squibb appoints Cristian Massacesi as EVP, Chief Medical Officer, and Head of Development

He most recently served as Chief Medical Officer of AstraZeneca and Alexion


Aurobindo to acquire Lannett Company for Rs. 2,185 Cr
News | July 31, 2025

Aurobindo to acquire Lannett Company for Rs. 2,185 Cr

The transaction aligns with Aurobindo’s strategic objective to expand its U.S. manufacturing footprint by enhancing its existing domestic capabilities


Akums’ Haridwar factory receives ANVISA GMP certification for sterile manufacturing plant
Drug Approval | July 28, 2025

Akums’ Haridwar factory receives ANVISA GMP certification for sterile manufacturing plant

This certification validates the plant’s robust capabilities in manufacturing a wide range of sterile dosage forms


Laurus Labs to invest €5 million in JV KRKA Pharma
News | July 27, 2025

Laurus Labs to invest €5 million in JV KRKA Pharma

The purpose of this investment is to meet the expenditure relating to the civil works to be undertaken for setting up of a manufacturing facility


Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
Clinical Trials | July 21, 2025

Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population


Aarti Drugs posts Q1 FY26 PAT higher at Rs. 54 Cr
News | July 21, 2025

Aarti Drugs posts Q1 FY26 PAT higher at Rs. 54 Cr

During Q1FY26, the company incurred Capex of ~Rs. 48.5 crores mainly towards capacity expansion, backward integration and finished formulation R&D


Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL
Drug Approval | July 15, 2025

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments


FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%
Drug Approval | July 15, 2025

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,


Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025