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Federal judge enters consent decree against drug distributors
Two Tennessee companies have been prevented from distributing drugs after a complaint they were supplying unapproved medications.
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US Food and Drug Administration (FDA)
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First treatment for patients with rare lung disease approved
The FDA has approved the first treatment for interstitial lung disease associated with systemic sclerosis or scleroderma.
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Fosaprepitant and Decitabine generics receive FDA approval
Generic treatments for blood/bone marrow disorders and acute nausea and vomiting associated with chemotherapy have gained FDA approval.
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EC approves expanded use of ustekinumab for ulcerative colitis
The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.
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Respiratory virus vaccine receives breakthrough therapy designation
The FDA has awarded a breakthrough therapy designation to an investigational prophylactic vaccine to treat respiratory syncytial virus in seniors.
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Developments in stability testing and evaluation
The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.
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Allowable levels of excipients in drug products
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
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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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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.
