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Results For "FDA"

2062 News Found

Piramal Pharma expands API capabilities at Digwal
News | June 15, 2022

Piramal Pharma expands API capabilities at Digwal

Site has a capital investment program of ~$30 million spent or committed over the last three years to expand capabilities and improve operational efficiencies


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


Amytrx Therapeutic's AMTX-100 CF3 moves to phase II clinical trial for atopic dermatitis
Clinical Trials | June 12, 2022

Amytrx Therapeutic's AMTX-100 CF3 moves to phase II clinical trial for atopic dermatitis

Amarex Clinical Research guides its client to phase II of FDA trials


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.


Novartis Scemblix shows better result for chronic myeloid leukemia trial
Clinical Trials | June 08, 2022

Novartis Scemblix shows better result for chronic myeloid leukemia trial

Scemblix (asciminib) continues to show superior efficacy with more-than-two-fold improvement in major molecular response rate vs. Bosulif (bosutinib) at 96 weeks


CMP Pharma announces calcium channel blocker ‘Norliqva’ availability
News | June 03, 2022

CMP Pharma announces calcium channel blocker ‘Norliqva’ availability

Norliqva was approved by the FDA on February 24, 2022 and is now available through normal retail distribution.


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


Glenmark Pharma reports revenue growth of 5.6% YoY in Q4
News | May 30, 2022

Glenmark Pharma reports revenue growth of 5.6% YoY in Q4

Glenmark Pharmaceuticals announced its financial results for the fourth quarter ended March 31, 2022