Breakthrough Therapy Designation granted to prostate cancer drug
The FDA has given the designation to niraparib for the treatment of gene-mutated castration-resistant prostate cancer.
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The FDA has given the designation to niraparib for the treatment of gene-mutated castration-resistant prostate cancer.
The FDA has announced its approval of Descovy, a PrEP method therapy, to reduce the risk of HIV-1 infection from sex.
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
The FDA has given a complete response letter to AstraZeneca for its PT010 treatment, regarding its New Drug Application.
Rituxan (rituximab) is the first approved treatment for children with rare vasculitis diseases, in which a patient’s small blood vessels become inflamed.
The drug daratumumab has been approved for treatment of multiple myeloma, demonstrating increased efficacy when used in combination with other drugs.
The Jynneos live, non-replicating vaccination for smallpox and monkeypox has been approved by the FDA for high-risk patients.
The FDA grants Orphan Drug Designation to treatments for rare diseases in R&D; here are the 10 most recent for oncologic conditions.
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
With the approval of the treatment, Rybelsus, there is a new option for treating type 2 diabetes without injections.
Darmerica LLC is voluntarily recalling two lots of quinacrine dihydrochloride due to a label mix-up.
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
Pharmaceutical Manufacturing Research Services has filed a lawsuit against the FDA after it rejected its application for opioids with updated labelling and appearance, meant to discourage misuse.
A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.
Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma.