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

462 News Found

Dr. Reddy's Lab launches sorafenib tablets in US
News | June 15, 2022

Dr. Reddy's Lab launches sorafenib tablets in US

Dr. Reddy's Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.


Eli Lilly gets FDA approval for alopecia drug
Drug Approval | June 15, 2022

Eli Lilly gets FDA approval for alopecia drug

Alopecia areata usually presents as a few small bald patches in the head


Philips announces positive research results from its TOBA II BTK clinical trial
Diagnostic Center | June 14, 2022

Philips announces positive research results from its TOBA II BTK clinical trial

First and only FDA-approved device of its kind demonstrates consistently high rates of target limb salvage and freedom from clinically-driven target lesion revascularization


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