Category: emd serono
Pharmaceutical drugs can work wonders for patients, whether it’s treating rare diseases or easing everyday maladies. But drugs can also be complex. What works for one patient may not for another, and side effects could be possible. Also, the longer that a drug is on the market, the more its manufacturer might learn and document […]
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available […]
EMD Serono’s Tepmetko is one of a number of targeted cancer therapies that have passed FDA muster in the past year. The decision sets up the German company’s pill for head-to-head competition with a Novartis drug targeting the same genetic signature.