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FDA
A new study out of Duke University added weight to the determination that asthma in children did not increase infection risk, children slow to get COVID vaccine and more COVID-19 news.
The U.S. FDA has approved Lynparza for the adjuvant treatment of patients diagnosed with germline BRCA-mutated HER2-negative high-risk early breast cancer.
Novartis released new data Monday from its Phase III SPR1NT trial that reinforces the benefits of Zolgensma.
This week is starting off strong with some positive clinical news from Ascendis Pharma, Can-Fite and BridgeBio.
AstraZeneca’s Fasenra hit a roadblock after the FDA issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
Bristol Myers Squibb and Nektar Therapeutics said their joint Phase III PIVOT IO-001 study did not meet two endpoints: progression-free survival and objective response rate.
An investigation into the estrogen-brain link will be led by the Tulane Brain Institute’s multidisciplinary team, whose expertise spans across the pharmacology, physiology and molecular biology industries.
The FDA has a full PDUFA calendar for the second half of March for New Drug Applications and Biologics License Applications. Here’s a look.
Across a range of indications, COVID-19-related and non-COVID-19-related, there was plenty of clinical trial news last week.
The discovery of a unique, inheritable resistance to Ebola infection has inspired the development of therapeutics that may not only be effective against Ebola but against COVID-19, as well.
Harpoon Therapeutics, Inc. has unfortunately announced that it will move to discontinue one of its promising T cell engager biologics, HPN424.
Cambridge Crossing will enable innovative drug discovery platforms for chemistry, protein engineering, structural and synthetic biology, among other key modalities.
The Russian invasion of Ukraine has hampered Ukrainian research to develop new treatments for infection from the SARS-CoV-2 virus and increased the risk of spreading virulent pathogens.
The drop in value has prompted MorphoSys to make drastic changes, such as discontinuing its U.S. operations and abandoning several pipeline projects.
The Orphazyme board of directors decided to cut 50% of its current global staff count after carefully considering its financial state.
The death toll related to COVID-19 is more than 6 million, according to the Johns Hopkins COVID-19 dashboard, but it has long been suspected that the toll is significantly higher.
FDA
Releuko is expected to launch in the third quarter of 2022 as a treatment for neutropenia, a low white blood cell condition experienced by chemotherapy patients.
The SEC said that Yum China, BeiGene, Zai Lab, HutchMed and ACM Research are all at risk if they do not give U.S. regulators access to their audit records.
Capricor Therapeutics announced less-than-stellar Q4 2021 and full-year 2021 financial results and said the company stopped efforts on its COVID-19 vaccine.
The two companies will work closely to harness the abilities of dopamine receptor modulators to help patients living with complex neuropsychiatric conditions.