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

594 News Found

Merck to initiate new Phase 3 clinical program for treatment of HIV-1 Infection
Clinical Trials | September 21, 2022

Merck to initiate new Phase 3 clinical program for treatment of HIV-1 Infection

Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir


Boehringer Ingelheim InPedILD Phase III trial showed encouraging results for both primary endpoints
Clinical Trials | September 06, 2022

Boehringer Ingelheim InPedILD Phase III trial showed encouraging results for both primary endpoints

New data from Boehringer Ingelheim support the potential use of nintedanib in children and adolescents with fibrosing interstitial lung disease


Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU
News | September 05, 2022

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.1-adapted bivalent COVID-19 vaccine booster in EU

CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine


USFDA approves first treatment option for generalized pustular psoriasis flares in adults
Drug Approval | September 03, 2022

USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares


US FDA issues 17 observations for Biocon Biologics sites
News | September 01, 2022

US FDA issues 17 observations for Biocon Biologics sites

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools


Stelis Biopharma’s flagship facility receives EIR from USFDA
Drug Approval | September 01, 2022

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise


Bayer showcases cancer study data at ESMO Congress 2022
News | September 01, 2022

Bayer showcases cancer study data at ESMO Congress 2022

On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors


Moderna files for emergency use of BA.4/BA.5 Omicron booster
Biotech | August 28, 2022

Moderna files for emergency use of BA.4/BA.5 Omicron booster

Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September


Merck gets fast track designation from the USFDA for anticoagulant therapy
Drug Approval | August 24, 2022

Merck gets fast track designation from the USFDA for anticoagulant therapy

Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis


USFDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | August 22, 2022

USFDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.