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Results For "approval"

2475 News Found

Stelis Biopharma's two biologics manufacturing facilities receive EU cGMP accreditation
Drug Approval | June 16, 2022

Stelis Biopharma's two biologics manufacturing facilities receive EU cGMP accreditation

Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation


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.


Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for HIV in South Africa
Public Health | June 15, 2022

Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for HIV in South Africa

This new formulation represents a significant improvement over protease inhibitor-containing paediatric ARV formulations that have been used in South Africa for decades.


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


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


China NMPA approves Tislelizumab for metastatic nasopharyngeal cancer
Drug Approval | June 12, 2022

China NMPA approves Tislelizumab for metastatic nasopharyngeal cancer

Tislelizumab is now approved in nine indications in China


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


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.


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