Regulatory
GenFit’s lead product candidate elafibranor snagged Breakthrough Therapy Designation from the U.S. Food and Drug Administration as a treatment for Primary Biliary Cholangitis (PBC) following strong Phase II results that demonstrated the safety and efficacy of the medication.
Renal cell carcinoma is also called renal cell cancer or renal cell adenocarcinoma. Approximately 90% of all kidney cancers are renal cell carcinomas.
The FDA said the approval of Teva’s product is the first generic naloxone nasal spray for use in a community setting by individuals without medical training.
FDA grants elafibranor Breakthrough Therapy Designation, based on Phase 2 data, for treatment of PBC (Primary Biliary Cholangitis) in adults with inadequate response to UDCA
Director Peter Marks said FY18 was productive and exciting as the FDA department continued to support the advancement of 21st century medicine.
COPD is a progressive disease associated with tobacco smoking, air pollution or occupational exposure. It results in difficulties in breathing and increasing episodes of breathlessness.
As Ned Sharpless takes over as acting commissioner of the U.S. Food and Drug Administration, he is not planning any disruptions or course corrections to the federal regulatory agency.
Poietis, 4D Bioprinting company, announces the issuance by the European Patent Office of a third patent covering its bioprinting technology
Company on Track to Submit NDA to FDA in Mid-2019
Karolinska Development’s portfolio company Aprea Therapeutics has from FDA received an Orphan Drug Designation for APR-246 for the treatment of patients with Myelodysplastic Syndromes having a TP53 mutation.
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