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Novo Nordisk files lawsuit against Mylan for generic application
The two pharmaceutical companies are facing a legal battle after Mylan filed a new drug application for a generic of Novo Nordisk’s Victoza.
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XTANDI® treatment granted priority review by FDA
XTANDI® sNDA seeks to add an indication for men with prostate cancer that's spread but is sensitive to hormone therapy.
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OTC drug manufacturer receives warning letter for data integrity issues
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
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FDA and EMA align on 90 percent of marketing authorisation decisions
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
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US and India receive most warning letters from FDA
New research has found that of the 38 warning letters handed out by the FDA in 2019, the US and India received the vast majority.
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Investigational Zika vaccine receives Fast Track designation
An investigational Zika vaccine currently being evaluated in a Phase I study has been given a Fast Track designation by the FDA.
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Emcure Pharmaceuticals receives warning letter from FDA
A warning letter has been sent to Emcure Pharmaceuticals after an FDA facility inspection found that the company did not adequately investigate sterility failures.
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FDA approves IND application for coeliac treatment
The FDA has accepted an IND application for AG017, a new drug designed to treat the causes of coeliac disease which will soon enter new trials.
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Complete response letter handed to Sarepta Therapeutics
The pharmaceutical company has received a complete response letter for its golodirsen injection, which had been submitted for accelerated approval.
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RINVOQ™ arthritis treatment granted approval by FDA
The FDA has given its approval to RINVOQ for the treatment of active rheumatoid arthritis after the drug reached its endpoints in clinical trials.
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US appeals court overturns patent case for Jevtana
Sanofi has won the latest appeal for the patent of its top oncology product, Jevtana (cabazitaxel).
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Two lots of migraine medication have been recalled
Pfizer has volountarily recalled the migraine medication Relpax because of the potential presence of Pseudomonas and Burkholderia.
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FDA grants Rozlytrek cancer treatment approval
The cancer therapeutic, Rozlytrek, has gained FDA approval as well as Priority Review, Breakthrough Therapy and Orphan Drug Designations.
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Complete response letter sent for two generic products
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
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New drug for treatment-resistant forms of tuberculosis approved
Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.