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Results For "U.S"

1563 News Found

Sanofi Dupixent gets USFDA nod for atopic dermatitis
Drug Approval | June 10, 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood


GE Healthcare’s molecular imaging solutions enable precision health & theranostics for prostate cancer
News | June 10, 2022

GE Healthcare’s molecular imaging solutions enable precision health & theranostics for prostate cancer

Healthcare is timely and personal – and its delivery should be too


Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis
Drug Approval | June 09, 2022

Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis

TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.


Halozyme announces commercial launch of testosterone undecanoate 'TLANDO'
News | June 08, 2022

Halozyme announces commercial launch of testosterone undecanoate 'TLANDO'

TLANDO was approved by the U.S. Food and Drug Administration (FDA) on March 28, 2022.


FDA publishes ANP’s polymeric drug excipient DMF
Drug Approval | June 06, 2022

FDA publishes ANP’s polymeric drug excipient DMF

The DMF#36513 demonstrates ANP’s success in the development of its “Plug and Play” drug delivery platform.


ANI Pharmaceuticals consolidates operation post Novitium acquisition
News | June 06, 2022

ANI Pharmaceuticals consolidates operation post Novitium acquisition

Operations at Oakville, Canada manufacturing plant expected to end by first quarter 2023


APhA appoints Ilisa Bernstein Interim CEO
People | June 06, 2022

APhA appoints Ilisa Bernstein Interim CEO

Dr. Bernstein will tap into her decades of leadership and strategy experience as she transitions into this new role at APhA


Mitsubishi Tanabe Pharma America presents 48-week results from phase 3 safety clinical study of Radicava ORS
News | June 03, 2022

Mitsubishi Tanabe Pharma America presents 48-week results from phase 3 safety clinical study of Radicava ORS

Radicava ORS was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2022


LEO Pharma strengthens its commercial organization
News | June 03, 2022

LEO Pharma strengthens its commercial organization

The refocused commercial set-up will increase organizational efficiency and alignment across all commercial functions globally


USFDA accepts dupilumab for priority review in adults with prurigo nodularis
Drug Approval | June 01, 2022

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved