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Results For "regulatory-approval"

316 News Found

Biomind Labs announces positive results of Phase 2 clinical trial of BMND08 for depression & anxiety in Alzheimer’s disease
Clinical Trials | March 03, 2024

Biomind Labs announces positive results of Phase 2 clinical trial of BMND08 for depression & anxiety in Alzheimer’s disease

Clinical findings support the safety and efficacy of BMND08 at a maximum dosage of 12mg


Suven announces merger of Cohance Lifesciences
News | March 01, 2024

Suven announces merger of Cohance Lifesciences

The overall transaction is expected to conclude over next 12-15 months subject to receipt of all relevant shareholder and regulatory approvals


TechInvention Lifecare breaks ground of its GCMC
Biotech | February 29, 2024

TechInvention Lifecare breaks ground of its GCMC

The objective of GCMC is well aligned to WHO’s call to action and India’s National Biotechnology Development Strategy


Moderna posts Q4 2023 revenue at US$ 2.8 billion
News | February 23, 2024

Moderna posts Q4 2023 revenue at US$ 2.8 billion

Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance


Novartis to acquire MorphoSys AG for Euro 2.7 billion to strengthen oncology pipeline
News | February 09, 2024

Novartis to acquire MorphoSys AG for Euro 2.7 billion to strengthen oncology pipeline

Pelabresib recently met its primary endpoint of spleen volume reduction and demonstrated favorable trends in symptom improvement


Jubilant Pharmova Singapore to sell its entire 25.8% stake in Sofie Biosciences, USA
News | January 29, 2024

Jubilant Pharmova Singapore to sell its entire 25.8% stake in Sofie Biosciences, USA

JPL plans to sell its entire 25.8% equity stake in Sofie for aggregate proceeds of about US$ 139.43 million


Syngene Q3 FY 24 PAT up 4% to Rs 115 Cr
News | January 26, 2024

Syngene Q3 FY 24 PAT up 4% to Rs 115 Cr

For 9 months period ended December 2023, the company’s PAT up 16% to Rs 330 crores (before exceptional items)


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


Parexel collaborates with Japanese Foundation for cancer research
News | January 17, 2024

Parexel collaborates with Japanese Foundation for cancer research

Collaboration streamlines patient access to oncology clinical trials


Palatin completes sale of Vyleesi to Cosette Pharmaceuticals for up to $171 mn
News | January 02, 2024

Palatin completes sale of Vyleesi to Cosette Pharmaceuticals for up to $171 mn

Vyleesi is the first and only as-needed treatment approved by the Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)