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Results For "U.S.-Food-and-Drug-Administration"

489 News Found

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Drug Approval | June 14, 2022

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial


Marinus expands enrollment criteria to support recruitment in Phase 3 RAISE Trial in refractory status epilepticus
Diagnostic Center | June 10, 2022

Marinus expands enrollment criteria to support recruitment in Phase 3 RAISE Trial in refractory status epilepticus

Marinus has broadened inclusion criteria in the RAISE trial to allow for enrollment of patients previously treated with IV anesthesia.


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


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.


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


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


FDA approves Roche’s Evrysdi for use in babies under two months with SMA
Drug Approval | June 01, 2022

FDA approves Roche’s Evrysdi for use in babies under two months with SMA

Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to date


USFDA approves two Opdivo-based regimens
Biotech | May 29, 2022

USFDA approves two Opdivo-based regimens

Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers