Tag:FDA

Takeda Pharmaceutical gets FDA nod for lung cancer drug Exkivity

The U.S. Food and Drug Administration had approved Takeda Pharmaceutical Co.’s drug, Exkivity, to treat a particular type of lung cancer, the...

Ascendis gets FDA nod on once a week pediatric growth hormone deficiency injection

Ascendis Pharma Lonapegsomatropin-tcgd injection, Skytrofa, which is a weekly somatropin formulation, has recently been approved by FDA for children having growth hormone...

FDA rejects AstraZeneca and FibroGen’s roxadustat NDA for CKD related anemia

FibroGen and AstraZeneca new drug application (NDA) for roxadustat to treat anaemia associated with chronic kidney disease (CKD) has been rejected by...

Covid-19 booster shot roll out plan expected to be finalized by FDA by end of Q3

The U.S. Food and Drug Administration (FDA), in a discussion, proposed an early September timeline for rolling out a strategy for COVID-19...

FDA adds Guillain-Barre syndrome warning to Johnson & Johnson Covid-19 vaccine

The US-based drug regulatory agency, FDA, has updated the label on coronavirus vaccine Johnson and Johnson to forewarn about the possible increasing

AstraZeneca and FibroGen hit FDA committee’s safety data firewall for roxadustat

Two roxadustat partners AstraZeneca and FibroGen have received objections regarding safety concerns of their drug from the FDA after which the two companies

Vertex scores FDA nod for kids’ cystic fibrosis drug Trikafta

Trikafta was approved by FDA for the treatment of Cystic Fibrosis in patients aged 6 to 11 years, after receiving approval to be used in patients of ages 12 and up

Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm

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Repair Biotechnologies to Leverage Genevant Sciences’ LNP Technology for Atherosclerosis Treatment

Repair Biotechnologies has joined forces with Swiss company Genevant Sciences to gain access to Genevant’s lipid nanoparticle (LNP) technology...
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AbbVie’s Parkinson’s Drug Meets Phase 3 Trial Goal

AbbVie has disclosed that its late-stage monotherapy prospect substantially decreased the impact of the condition in patients as contrasted...

AstraZeneca Expands AI-Powered Immuno-Oncology Research Partnership with Immunai

Immunai, a biotechnology company based in New York, has partnered with AstraZeneca in a multiyear endeavor to try and...

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Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm