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Moderna Announces Submission of Initial Data to U.S. FDA for Its COVID-19 Vaccine Booster

Sep 1, 2021
Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines announced it has initiated its submission to the U.S. Food and Drug Administration (FDA)…
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On-body biosensors: A human factors development approach

Sep 1, 2021
SMi Reports: Exploring therapeutic applications of connected on-body devices at Medical Wearables for Biosensors conference Biosensors and wearable devices are gaining substantial…
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Digital applications for on-body devices discussed at Wearable Injectors and Connected Devices…

Sep 1, 2021
SMi Group reports: The latest innovations in digital health and on-body drug delivery for the pharmaceutical industry The upcoming conference in October will consider key…
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Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a…

Aug 31, 2021
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell announced that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone…
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Senhwa’s Silmitasertib, COVID-19 Drug Candidate, Receives Positive Interim Review from Data…

Aug 31, 2021
Senhwa Biosciences, Inc. a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that its oral new drug,…
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Data from Multiple Studies Show Positive Outcomes with Gala Therapeutics’ RheOx System for…

Aug 31, 2021
Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announced new data from multiple clinical studies that demonstrate improvements in chronic…
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Epygenix Therapeutics Announces FDA Acceptance of IND to Initiate a Clinical Trial of EPX-100 to…

Aug 30, 2021
Epygenix Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare and intractable genetic epilepsy, announced today that the U.S. Food and Drug Administration…
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Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative…

Aug 30, 2021
Roche announced that the company has made the decision to voluntarily withdraw the US accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane,…
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UCB Announces BRIVIACT (brivaracetam) CV Now FDA-Approved to Treat Partial-Onset Seizures in…

Aug 30, 2021
UCB announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BRIVIACT (brivaracetam) CV tablets, oral solution, and injection to treat…
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Novartis sabatolimab receives orphan drug designation from the European Commission for…

Aug 30, 2021
Novartis announced that the European Commission (EC) has granted orphan drug designation to sabatolimab (MBG453) for the treatment of myelodysplastic syndromes (MDS), based on clinical…
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Industry Reports

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Press Releases

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