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

462 News Found

NATCO announces tentative approval to its ANDA for Trabectedin
Drug Approval | August 18, 2022

NATCO announces tentative approval to its ANDA for Trabectedin

According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.


FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer
Drug Approval | August 17, 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


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


Dr. Reddy's launches Bortezomib for Injection, 3.5 mg Single-Dose Vial in the U.S. Market
Drug Approval | July 28, 2022

Dr. Reddy's launches Bortezomib for Injection, 3.5 mg Single-Dose Vial in the U.S. Market

The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022


Sun Pharma and Cosmo announce territory expansion of license and supply agreements for WINLEVI
Supply Chain | July 26, 2022

Sun Pharma and Cosmo announce territory expansion of license and supply agreements for WINLEVI

Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia.


Dr. Reddy's announces the first-to-market, OTC launch of Allegra-D in the US market
Drug Approval | July 24, 2022

Dr. Reddy's announces the first-to-market, OTC launch of Allegra-D in the US market

Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.


Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease
News | July 20, 2022

Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease

The Elecsys Amyloid Plasma Panel has the potential to ensure better identification of patients that require further confirmatory testing, supporting a more timely and accessible diagnosis.


Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer
News | July 18, 2022

Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer

The FDA's Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people


Enveda appoints Vanitha Sekar as Chief Business Officer
People | July 16, 2022

Enveda appoints Vanitha Sekar as Chief Business Officer

She joins Enveda from Gilead Sciences