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Pharma News

Is the FDA About to Break?
Is the FDA About to Break?
Job cuts at the FDA spark concern, with Robert Califf saying the agency as we know it is “finished.”
New Target for Lyme Disease Vaccine Shows Promise in Preclinical Models
New Target for Lyme Disease Vaccine Shows Promise in Preclinical Models
Lyme disease infects about 476,000 people in the United States each year and can lead to severe complications such as ongoing fatigue and joint issues. However, no human vaccine is yet commercially av...
China’s NMPA authorises Santen’s glaucoma treatment application
China’s NMPA authorises Santen’s glaucoma treatment application
China’s National Medical Products Administration (NMPA) has approved the marketing authorisation application of Santen Pharmaceutical’s Tapcom to treat individuals with open-angle glaucoma...
Novo Nordisk Commits $1.12 Billion to Expand Ozempic Production in Brazil
Novo Nordisk Commits $1.12 Billion to Expand Ozempic Production in Brazil
Novo Nordisk, the Danish pharmaceutical leader, announced a R$6.4 billion ($1.12 billion) investment in its Montes Claros facility in Minas Gerais, Brazil. This expansion aims to double the pl...
ABL Bio and GSK link on neurodegenerative conditions
ABL Bio and GSK link on neurodegenerative conditions
ABL Bio has announced a global licensing agreement with GSK, allowing the latter to develop medicines for neurodegenerative conditions.
FDA awards Оrphan Drug Designation status to Sanofi’s rilzabrutinib for two rare conditions
FDA awards Оrphan Drug Designation status to Sanofi’s rilzabrutinib for two rare conditions
Sanofi’s oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor rilzabrutinib has gained US Food and Drug Administration (FDA) Оrphan Drug Designation (ODD) to treat tw...
US FDA declines to approve Aldeyra's eye disease drug
US FDA declines to approve Aldeyra's eye disease drug
The U.S. Food and Drug Administration has once again declined to approve Aldeyra Therapeutics, opens new tab treatment for dry eye disease, the company said on Thursday, sending its shares down 73%...
Daiichi and AstraZeneca’s Enhertu gains EC approval for breast cancers
Daiichi and AstraZeneca’s Enhertu gains EC approval for breast cancers
The European Commission (EC) has approved Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) for use as a single agent to treat adults with unresectable or metastatic ...
New melanoma therapy prevents brain metastasis in preclinical studies
New melanoma therapy prevents brain metastasis in preclinical studies
A government-funded research team has identified focal adhesion kinase (FAK) as a key driver of melanoma metastasis to the brain.
FDA Grants Fast Track Designation to Investigational Tau-Targeting Therapy for Alzheimer Disease
FDA Grants Fast Track Designation to Investigational Tau-Targeting Therapy for Alzheimer Disease
BIIB080 is the first tau-targeting antisense oligonucleotide therapy to reach clinical trials for Alzheimer's disease. Phase 1b trials showed positive cognitive trends and reduced tau protein leve...
Preclinical success for gene control system for Rett Syndrome Rett Syndrome
Preclinical success for gene control system for Rett Syndrome Rett Syndrome
Scientists have developed a new transgene control system that shows early promise for treating rare brain disorder Rett syndrome.
Neoadjuvant Darovasertib Receives FDA
Neoadjuvant Darovasertib Receives FDA
Neoadjuvant Darovasertib Receives FDA Breakthrough Therapy Designation for Uveal melanoma
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