Category: Approval

April 22, 2022 Off

Novo Nordisk’s NovoSeven Recommended for Approval for the Treatment of Severe Postpartum Haemorrhage by the EMA

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an extension of the Novo Nordisk’s NovoSeven (eptacog alfa) label to include treatment of women suffering from severe haemorrhage after giving birth, when medications used to induce uterine contractions and reduce bleeding (uterotonics) are insufficient to stop the bleeding.

April 20, 2022 Off

AbbVie’s Crohn’s Disease Drug to Treat Patients in UK

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The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for AbbVie’s risankizumab for treatment of adults and adolescents (16-17 years) with Crohn’s Disease (CD) who have had an inadequate response to, lost response to or were intolerant or contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies, vedolizumab and ustekinumab.

April 11, 2022 Off

Adrenomed Gets €7,4M to Develop Covid-19 Drug

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Adrenomed AG, the vascular integrity company, has announced that its proprietary sepsis drug candidate Adrecizumab (HAM8101) received a funding commitment of € 7.4 million from the German Federal Ministry of Education and Research (BMBF) as part of the German funding initiatives for the clinical development of COVID-19 drugs and their manufacturing capabilities.

April 2, 2022 Off

Kite’s Yescarta Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)

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Kite, a Gilead Company (Nasdaq: GILD), has announced the U.S. Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.