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FDA grants fast-track designation for Karyopharm's selinexor in penta-refractory multiple myeloma firstwordpharma
April 11, 2018
Karyopharm Therapeutics announced Tuesday that the FDA granted fast-track status to selinexor, the company's oral selective inhibitor of nuclear export (SINE)
FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information biospace
April 10, 2018
U.S. Food and Drug Administration Releases Order to Limit Sales and Distribution of Essure Equipment
RegeneRx Announces Outcome of FDA Discussions for Development of RGN-259 for Dry Eye Syndrome biospace
April 10, 2018
RegeneRx Biopharmaceuticals, Inc. Announces Phase 3 Clinical Trial Completed by ReGenTree LLC and US FDA Joint Venture
Fischer Medical Receives U.S. FDA 510(k) Clearance to Market Bloom2 Cardiac Stimulator biospace
April 10, 2018
Fischer Medical has announced that the Bloom2 cardiac electrophysiology stimulator device has received U.S. Food and Drug Administration (FDA) 510(k) clearance.
Alembic Pharma gets US FDA nod for Acyclovir ointment expressbpd
April 10, 2018
The drug is used for management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients
FDA accepts AstraZeneca’s licensing application for leukaemia drug pharmaceutical-technology
April 09, 2018
AstraZeneca and MedImmune, its global biologics research and development arm, have announced that the FDA has accepted the Biologics License Application (BLA) for moxetumomab pasudotox for adult patients with hairy cell leukaemia (HCL).
FDA Grants Fast Track Designation for TAR-200 GemRIS americanpharmaceuticalreview
April 09, 2018
TARIS Announces U.S. Food and Drug Administration (FDA) Approves TAR-200 (GemRIS) Fast Track
FDA Grants Orphan Drug Designation for BPN14770 americanpharmaceuticalreview
April 09, 2018
Tetra Discovery Partners announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for BPN14770 for the treatment of Fragile X Syndrome
FDA, European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib americanpharmaceuticalreview
April 09, 2018
Pfizer Announces U.S. Food and Drug Administration (FDA) Accepts New Drug Application from the Company and Approves Priority Review of Damotinib
USFDA accepts BLA for moxetumomab pasudotox by AstraZeneca biospectrumasia
April 08, 2018
The FDA has granted the moxetumomab pasudotox BLA Priority Review status with a Prescription Drug User Fee Act date set for the third quarter of 2018

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