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FDA and EMA accept regulatory submissions for UCB’s bimekizumab
pharmatimes
September 27, 2020
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both accepted marketing application submissions for UCB’s psoriasis treatment bimekizumab.
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Biopharma Leaders Unite To Stand With Science
drugs.com
September 24, 2020
The CEOs today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.
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IND granted to Ampion as COVID-19 treatment after Phase I study
europeanpharmaceuticalreview
September 23, 2020
The FDA has given the green light to an IND and further Phase I clinical trial of Ampio Pharmaceuticals’ Ampion as an inhaled COVID-19 therapy.
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MediWound Announces NexoBrid BLA Acceptance for Severe Thermal Burns
americanpharmaceuticalreview
September 23, 2020
MediWound announced the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness..
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FDA Approves Study to Investigate Cell Therapy to Treat COVID-19 Related MIS-C
americanpharmaceuticalreview
September 23, 2020
The Cura Foundation in collaboration with The Marcus Foundation, Sanford Health and Alliance for Cell Therapy Now, is supporting a clinical trial of human cord tissue mesenchymal stromal cells (hCT-MSC) to treat children with ...
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FDA Publishes Comparative Performance Data for COVID-19 Tests
americanpharmaceuticalreview
September 23, 2020
The U.S. Food and Drug Administration (FDA) has published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests ...
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Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients with Localized, No
drugs.com
September 23, 2020
Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Pedmark...
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FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol
drugs.com
September 23, 2020
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted for Priority Review a Biologics License Application for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous...
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FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair
drugs.com
September 23, 2020
Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug Administration (FDA) has approved Xaracoll for acute postsurgical pain relief for up to 24 hours...
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FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
drugs.com
September 23, 2020
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets.