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Results For "FDA-approval"

460 News Found

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer
Drug Approval | August 09, 2022

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy


Biocon Sdn. Bhd. enters Malaysia Book of Records
Biotech | August 08, 2022

Biocon Sdn. Bhd. enters Malaysia Book of Records

The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR


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


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


USFDA approves Novartis Kymriah CAR-T cell therapy
Biotech | May 29, 2022

USFDA approves Novartis Kymriah CAR-T cell therapy

68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile


Borrena approval strengthens Pfizer position in China NSCLC market: GlobalData
News | May 25, 2022

Borrena approval strengthens Pfizer position in China NSCLC market: GlobalData

According to GlobalData’s ‘Pharmaceutical Intelligence Center’, the number of diagnosed prevalent cases of ALK-mutant NSCLC in China is estimated to grow at a CAGR of 5.3% from 22,725 in 2021 to 31,902 in 2029


My aim is to help the pharmaceutical industry develop a winning strategy: Dr Rupali Paranjape
interviews | May 23, 2022

My aim is to help the pharmaceutical industry develop a winning strategy: Dr Rupali Paranjape

Dr Rupali Paranjape, an experienced regulatory and compliance consultant and author of Blue Ocean of Compliance shares insights on her book in an interview with Thomas C Thottathil, Editor, www.indianpharmapost.com