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Results For "regulatory-approval"

316 News Found

Aptar’s nasal unidose system delivers FDA-approved neffy
News | August 19, 2024

Aptar’s nasal unidose system delivers FDA-approved neffy

This marks the first regulatory approval worldwide for nasally-delivered epinephrine


Merck to acquire investigational B-Cell depletion therapy from Curon Biopharmaceutical
News | August 11, 2024

Merck to acquire investigational B-Cell depletion therapy from Curon Biopharmaceutical

CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies Merck’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases


32 projects completed under PLI Scheme for promotion of domestic manufacturing of Critical KSMs/DIs and APIs
Policy | August 10, 2024

32 projects completed under PLI Scheme for promotion of domestic manufacturing of Critical KSMs/DIs and APIs

Against targeted investment of Rs. 3,938 crore, investments worth Rs. 4,024 crores have been made under scheme


Bayer announces positive topline results for Nubeqa from Phase III trial in men with mHSPC
Clinical Trials | July 23, 2024

Bayer announces positive topline results for Nubeqa from Phase III trial in men with mHSPC

Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT


dsm-firmenich to sell MEG-3 fish oil business to KD Pharma Group
News | July 22, 2024

dsm-firmenich to sell MEG-3 fish oil business to KD Pharma Group

dsm-firmenich decided to de-prioritize certain business segments, including the MEG-3 business


GSK and CureVac restructure collaboration into new licensing agreement
News | July 05, 2024

GSK and CureVac restructure collaboration into new licensing agreement

CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced


Cipla EU to invest an additional € 3 million in Ethris
News | June 19, 2024

Cipla EU to invest an additional € 3 million in Ethris

Cipla had earlier invested € 15 million in Ethris in 2022


Suven to acquire a majority stake in CDMO player ‘Sapala Organics’
News | June 14, 2024

Suven to acquire a majority stake in CDMO player ‘Sapala Organics’

Sapala has a strong customer base including innovator Pharma, CDMOs & diagnostic companies


Kardium announces US$ 104 million in new financing for innovative Atrial Fibrillation Treatment
News | June 13, 2024

Kardium announces US$ 104 million in new financing for innovative Atrial Fibrillation Treatment

Private financing round supported by Fidelity Management & Research Company, T. Rowe Price and Durable Capital Partners


Hyperfine bringing Swoop to India through distribution partnership with Radiosurgery Global
Medical Device | May 30, 2024

Hyperfine bringing Swoop to India through distribution partnership with Radiosurgery Global

Strategic focus on India aims to make the Swoop® portable MR brain imaging system commercially available in a vast and underserved MRI market