FDA

News and Updates by the Food and Drugs Administration (FDA)

Novavax Strikes Deal to Sell Czech Republic Production Plant to Novo Nordisk for $200 Million

Novavax, Inc., an international leader in protein-based vaccines utilizing its Matrix-M adjuvant, has declared that it has secured a definitive transaction to divest its Bohumil, Czech Republic production site to Novo Nordisk for $200 million. The deal encompasses the transfer

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Ono Pharma Partners with Congruence for Innovative Small Molecule Correctors in Oncology

Ono Pharmaceutical Co., Ltd. has revealed a strategic partnership agreement with Congruence Therapeutics, a cutting-edge biotechnology company based in Montreal, Canada. This collaboration focuses on developing new small molecule correctors targeting multiple protein pathways in the field of oncology, utilizing

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Health Canada Gives Nod to Astellas Pharma’s Veozah: A Groundbreaking Non-Hormonal Option for Menopausal VMS Treatment

Astellas Pharma Canada, Inc. has announced Health Canada’s approval of Veozah (fezolinetant film-coated tablets) as the pioneering non-hormonal solution designed to address moderate to severe vasomotor symptoms related to menopause. As women transition through menopause, a phase that may dominate

Health Canada Gives Nod to Astellas Pharma’s Veozah: A Groundbreaking Non-Hormonal Option for Menopausal VMS Treatment Read More »

DCO India Appeals to Karnataka Chief Minister for Revocation of State Drug Controller’s Suspension

The Drug Control Officers India Welfare Association (DCO India), representing both active and retired drug regulation officials nationwide, has called upon the Karnataka government to reassess the suspension of Dr. S Umesh, the state’s drug controller. This action followed reports

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Pharmexcil Requests Member Input on Overcoming Export Challenges and Innovative Solutions

In a strategic move to boost India’s global pharmaceutical presence by tackling export-related challenges, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) has extended an invitation to its members to point out obstacles and suggest inventive growth strategies. Underlining the

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Delhi Court Urges Government to Consider Inclusion of Ichthyosis as a Disability under RPwD Act

The Delhi High Court has prompted the central authority to contemplate a submission from the Center for Ichthyosis Related Members Foundation, an organization devoted to supporting individuals with Ichthyosis or those connected to them. The plea seeks recognition of Ichthyosis

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Genethon and Hansa Initiate Phase 2 Trial of Imlifidase as Pre-Therapy to GNT-0003 for Advanced Crigler-Najjar Syndrome

Hansa Biopharma, an innovative commercial biopharmaceutical entity, together with Genethon, a leader in the sphere of gene therapy for rare genetic disorders, announced the launch of GNT-018-IDES. This is a phase 2 clinical trial aimed at individuals with Crigler-Najjar syndrome

Genethon and Hansa Initiate Phase 2 Trial of Imlifidase as Pre-Therapy to GNT-0003 for Advanced Crigler-Najjar Syndrome Read More »