Coronavirus Treatment Acceleration Program

1 April 2020 - FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program.  ...

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Samsung Bioepis announces FDA approval of 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb)

24 March 2020 - 150 mg and 420 mg vial of Ontruzant are now approved. ...

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U.S. FDA approves supplemental new drug application for expanded indication of Eucrisa (crisaborole) 2% ointment in children as young as 3 months of age with mild-to-moderate atopic dermatitis

24 March 2020 - Eucrisa is the first and only 100% steroid-free, topical prescription medication approved for patients as young as ...

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Biosimilar pegfilgrastim on the PBS - information for health professionals and patients

24 March 2020 - The first biosimilar brand of pegfilgrastim (Ziextenzo) has listed on the PBS on 1 March 2020.  ...

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The drug helping coronavirus patients

24 March 2020 - A flash of potential good news from the front lines of the coronavirus pandemic:  ...

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An update on the 2020 annual meeting in Beijing, China

20 March 2020 - Based on the balance of the evidence before the Board, and with the strong support of our ...

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Dentists banned from prescribing potential COVID-19 drug to self, family

24 March 2020 - The Australian government has rushed through an emergency regulation banning dentists from prescribing an arthritis drug ...

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COVID-19: hydroxychloroquine

24 March 2020 - There has been a lot of interest around the use of hydroxychloroquine for treatment of COVID-19 ...

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Helsinn announces European approval of the IV formulation of Akynzeo (fosnetupitant with palonosetron)

23 March 2020 - Helsinn today announces that the European Commission has approved the intravenous formulation of Akynzeo, (a fixed ...

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Edaravone for amyotrophic lateral sclerosis: barriers to access and lifeboat ethics

23 March 2020 - Despite its unavailability in Canada, patients legally imported the drug under provisions of the Canadian Food and ...

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EMA publishes agenda for 23-26 March CHMP meeting

23 March 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Rush to raise funds for large COVID-19 drug trial in Australian hospitals

23 March 2020 - Australian researchers behind a new clinical trial of two drugs to treat COVID-19 are desperate to ...

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COVID-19 and processing times

23 March 2020 - At present, TLV's operations continue as usual.  ...

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Eiger BioPharmaceuticals completes submission of new drug application to FDA for lonafarnib for treatment of progeria and progeroid laminopathies

23 March 2020 - Progeria MAA submitted to EMA and granted accelerated assessment. ...

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Intra-Cellular prices schizophrenia drug at $1,320 per month

23 March 2020 - Intra-Cellular Therapies said on Monday its lead drug to treat schizophrenia was now available at U.S. ...

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FDA and EMA collaborate to facilitate SARS-CoV-2 vaccine development

23 March 2020 - Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed ...

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