Paion announces submission of the marketing authorisation application for remimazolam in procedural sedation to the European Medicines Agency

20 November 2019 - The Specialty Pharma Company Paoin today announces that a marketing authorisation application for remimazolam, Paion’s ultra-short-acting ...

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Doctors who helped develop heart drug now balk at $225,000/year price

19 November 2019 - Wearing a revolutionary-era tricorn hat, doctor Mathew Maurer stood at a lectern in front of an ...

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FDA approves first treatment for inherited rare disease

20 November 2019 - Today, the U.S. FDA granted approval to Givlaari (givosiran) for the treatment of adult patients with acute ...

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European Commission approves two new regimens of Merck’s Keytruda (pembrolizumab) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma

20 November 2019 - Approval based on significant overall survival findings from Phase 3 KEYNOTE-048 trial. ...

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Alkermes submits new drug application to U.S. FDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder

19 November 2019 - Alkermes today announced that it has submitted a new drug application to the U.S. FDA seeking ...

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Newron receives FDA rare paediatric disease designation for sarizotan for the treatment of Rett syndrome

19 November 2019 - Newron announced today that the U.S. FDA has granted the rare paediatric disease designation for sarizotan, ...

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Generic drug approvals soar, but patients still go without

19 November 2019 - Brand name makers’ patent action limits release of the lower-price medicines, hindering cost-control efforts. ...

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Medexus granted priority review status for Gliolan by Health Canada

19 November 2019 - Medexus Pharmaceuticals today announced that Health Canada has granted priority review status for the new drug ...

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Genmab announces European marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone in frontline multiple myeloma

19 November 2019 - Approval based on data from Phase III MAIA study. ...

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Orphazyme receives breakthrough therapy designation for arimoclomol in Niemann-Pick disease Type C

19 November 2019 - Orphazyme today announces that the US FDA has granted breakthrough therapy designation for arimoclomol, an investigational drug ...

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FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate

19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...

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In a rare political move, prominent biotech venture capitalists speak out against Pelosi’s drug pricing bill

18 November 2019 - A group of top biotech venture capitalists are issuing a stark warning to Congress: They won’t ...

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European Medicines Agency grants Orchard Therapeutics accelerated assessment of OTL-200 for patients with metachromatic leukodystrophy

18 November 2019 - Orchard Therapeutics today announced that the CHMP of the EMA has granted an accelerated assessment for OTL-200, ...

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Levo Therapeutics receives fast track designation from FDA for intranasal carbetocin for the treatment of Prader-Willi syndrome

18 November 2019 - Levo Therapeutics announced today that the U.S. FDA has granted Fast Track designation for LV-101 (intranasal carbetocin) ...

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Seelos Therapeutics receives FDA fast track designation for intranasal racemic ketamine (SLS-002)

18 November 2019 - Seelos Therapeutics today announced the U.S. FDA has granted fast track designation to its new, investigational intranasal ...

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