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A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.

The UK Medicine and Healthcare products Regulatory Agency has released a revision to its standards for ensuring high quality of biologic products.

Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma.

Cosentyx®, a treatment for an inflammatory disease has met its primary endpoints in patients during a Phase III trial.

The market for containment facilities and containment manufacturing will increase in the future, due to a growing demand for oncology treatments.

Farxiga (dapagliflozin) has been given Fast Track designation by the FDA to reduce the risk of cardiovascular death.

New vaccine patch has showed no negative side effects and could lead to a replacement of needle-based vaccination methods.

The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.

17 September 2019 | By CPhI Worldwide

CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.

Nucala is the first biologic approved in the US for six- to 11-year-old children with severe eosinophilic asthma by the FDA.

Purdue has filed for bankruptcy protection after a settlement offer from the company over the opioid crisis was rejected by 24 states.

The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.

Kenya has become the third African country to introduce the world’s first malaria vaccine into the country, in a phased pilot programme.

The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.

GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.