Drug Approval | July 26, 2023
NATCO files generic Erdafitinib Tablets in USA
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The maker of ivermectin/pyrantel, the #1 vet-recommended and #1 dog-preferred real beef chew introduces the latest innovation in its portfolio
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
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 stands on the forefront of healthcare change to turn innovative science into value for patients
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
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
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
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