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Mylan generic of lung cancer drug Alimta approved
Mylan NV's generic version Eli Lilly and Co’s lung cancer drug, Alimta, has been given tentative approval by the FDA.
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US Food and Drug Administration (FDA)
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On the edge of glory: how close are we to fully automated continuous biopharma production?
We’re getting closer to something special with regard to how we manufacture biopharmaceuticals. Loe Cameron explores where the continuous bioprocessing journey could take us and what it might mean for medicine manufacturers worldwide.
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Multiple myeloma treatment receives Orphan Drug Designation
Orphan Drug Designation has been granted to the CT053 anti-BCMA CAR-T programme for multiple myeloma treatment.
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Small molecules dominate FDA drug approvals this month
This August saw nine new green lights from the FDA, all small molecules, which makes up a third of the approvals this year.
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FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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Farxiga has been granted Fast Track status by the FDA
Fast Track designation has been granted to Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
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Significant number of drugs on the market not yet fully approved
A large number of drug manufacturers are failing to complete the FDA's Accelerated Approval Program, meaning not all available drugs are fully approved, finds a study.
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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.
