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Results For "Food-and-Drug-Administration"

1018 News Found

Novartis acquires DTx Pharma to develop siRNA therapies
News | July 19, 2023

Novartis acquires DTx Pharma to develop siRNA therapies

Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications


Lupin receives approval from USFDA for Chlorpromazine Hydrochloride Tablets USP
Drug Approval | July 14, 2023

Lupin receives approval from USFDA for Chlorpromazine Hydrochloride Tablets USP

Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.


Moderna announces regulatory submissions for its RSV vaccine
News | July 10, 2023

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia


Astellas receives FDA priority review for Zolbetuximab biologics license application
Drug Approval | July 10, 2023

Astellas receives FDA priority review for Zolbetuximab biologics license application

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


Lupin receives tentative approval from USFDA for Dolutegravir Tablets for oral suspension
Drug Approval | July 05, 2023

Lupin receives tentative approval from USFDA for Dolutegravir Tablets for oral suspension

Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)


Zydus receives final approval from the USFDA for Oxcarbazepine Tablets
Drug Approval | July 05, 2023

Zydus receives final approval from the USFDA for Oxcarbazepine Tablets

The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)


Lupin receives approval from FDA for Cyanocobalamin Nasal Spray
Drug Approval | July 04, 2023

Lupin receives approval from FDA for Cyanocobalamin Nasal Spray

Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)


Granules India successfully completes Two US FDA Audits in a span of 2 weeks
Drug Approval | July 03, 2023

Granules India successfully completes Two US FDA Audits in a span of 2 weeks

The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.


GSK receives USFDA Fast Track designation for investigational vaccine against gonorrhoea
News | June 28, 2023

GSK receives USFDA Fast Track designation for investigational vaccine against gonorrhoea

Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing


Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss
News | June 28, 2023

Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss

As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands