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Results For "Food-and-Drug-Administration"

1018 News Found

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting
Drug Approval | November 17, 2023

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer


Kesin Pharma announces FDA approval and availability of Likmez oral suspension
Drug Approval | November 15, 2023

Kesin Pharma announces FDA approval and availability of Likmez oral suspension

Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing


Lupin launches Rocuronium Bromide injection in US
Drug Approval | November 09, 2023

Lupin launches Rocuronium Bromide injection in US

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).


Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets
Drug Approval | November 08, 2023

Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets

This product will be manufactured at Lupin’s Pithampur facility in India


Lupin receives tentative approval from USFDA for Selexipag for injection
Drug Approval | November 04, 2023

Lupin receives tentative approval from USFDA for Selexipag for injection

This product will be manufactured at Lupin's Nagpur facility in India


The Prostate Cancer Foundation and Bayer announce Bayer – PCF Darolutamide Challenge Awards
News | November 03, 2023

The Prostate Cancer Foundation and Bayer announce Bayer – PCF Darolutamide Challenge Awards

In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer


NATCO Pharma announces successful completion of USFDA inspection
Drug Approval | November 02, 2023

NATCO Pharma announces successful completion of USFDA inspection

NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023


Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19
News | October 30, 2023

Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19

The companies plan to start a pivotal Phase 3 trial in the coming months


USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
Drug Approval | October 26, 2023

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer


Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer
News | October 25, 2023

Sumitomo Pharma announces authorization in Canada of Orgovyx for treatment prostate cancer

Orgovyx is the first and only oral GnRH receptor antagonist approved for advanced prostate cancer in Canada