EMA gives green light for 14 new medicines
The EU medicines watchdog, the European Medicines Agency (EMA), has approved 14 new products at its summer meeting in Amsterdam. This brings to 46 the total number of… read more.
The EU medicines watchdog, the European Medicines Agency (EMA), has approved 14 new products at its summer meeting in Amsterdam. This brings to 46 the total number of… read more.
Sandoz, a global leader in generic and biosimilar medicines, announced that the FDA has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat… read more.
Roche announced that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA… read more.
Pfizer Inc. and Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for… read more.
Patients who have suffered an intracerebral hemorrhage (bleeding stroke) who subsequently take statins appear to have a lower risk of having another stroke, especially an ischemic stroke, when… read more.
A new fund to fast-track patient access to potentially valuable new medicines may incentivise the pharmaceutical industry to develop high priced drugs for rare diseases with weak evidence… read more.
Medtronic plc has received CE (Conformité Européenne) Mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator (SCS). It is the first Medtronic SCS device to offer a… read more.
Revance Therapeutics, Inc. announced that the FDA has approved the first therapeutic indication for Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults. Daxxify, powered… read more.
Forxiga (dapagliflozin) from AstraZeneca. has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with… read more.
Arcutis Biotherapeutics, Inc. and Hangzhou Zhongmei Huadong Pharmaceutical Co, a wholly owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963), announced that the companies have entered into a strategic… read more.
Researchers at Texas A&M University will spearhead a groundbreaking project to revolutionize medication administration for pediatric patients, thanks to an approximately $3 million grant from the National Institutes… read more.
Pfizer Inc. announced the FDA has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received… read more.
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