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

461 News Found

FDA approves Bristol Myers Squibb’s Cobenfy
Drug Approval | September 28, 2024

FDA approves Bristol Myers Squibb’s Cobenfy

A first-in-class muscarinic agonist for the treatment of schizophrenia in adults


Sun Pharma presents clinical efficacy and safety data in severe dermatological conditions at 2024 EADV Congress
News | September 27, 2024

Sun Pharma presents clinical efficacy and safety data in severe dermatological conditions at 2024 EADV Congress

The company will also share results in two additional posters for deuruxolitinib


Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024
Biotech | September 25, 2024

Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024

These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity


Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19
News | September 23, 2024

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain
Drug Approval | September 06, 2024

Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain

This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II


Natco Pharma announces submission of TABRECTA to USFDA
Drug Approval | August 30, 2024

Natco Pharma announces submission of TABRECTA to USFDA

TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA


Bayer starts Phase III trial in non-small cell lung cancer
Diagnostic Center | August 30, 2024

Bayer starts Phase III trial in non-small cell lung cancer

First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations


Merck announces Phase 3 trial initiation for Bomedemstat
Diagnostic Center | August 27, 2024

Merck announces Phase 3 trial initiation for Bomedemstat

The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)


BI Sky Global successfully completes FDA MoCRA registration
Drug Approval | August 25, 2024

BI Sky Global successfully completes FDA MoCRA registration

MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States