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Zydus Cadila receives tentative USFDA approval for palbociclib capsules expresspharma
September 27, 2020
It is an anti-cancer medicine that interferes with the growth and spread of cancer cells in the body.
FDA grants priority review for Pfizer’s Xalkori in paediatric ALCL pharmaceutical-technology
September 27, 2020
Pfizer has secured priority review from the US Food and Drug Administration (FDA) for Xalkori (crizotinib) to treat relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) in children.
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.
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.
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.
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..
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 ...
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 ...
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...
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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