Delivers up-to-date industry news on topics like drug approvals, product recalls, company expansions and acquisitions, market trends for all OSD forms, as well as excipients, packaging and supply chain issues. Monitors market trends in specific drug categories as well as in supplements/nutraceuticals. Provides updates on clinical trials. Includes alerts about new or upcoming regulatory issues.
The facility is one of nine U.S. manufacturing sites that Lilly has announced since 2020.
read more
Augmentin XR received approval after just two months via the CNPV pilot program, marking the first drug to win approval using the new pathway.
read more
The FDA has delayed its decision about tolebrutinib for a second time and Sanofi will not pursue approval in primary progressive multiple sclerosis.
read more
The closure will eliminate 91 jobs, with some workers being offered transfers to positions within Roquette.
read more
A single-tablet regimen combining bictegravir and lenacapavir could potentially transform the HIV treatment landscape.
read more
The deal will give BioMarin Amicus’s lead oral drug, Galafold, approved in 2018 for Fabry disease.
read more
An oral drug for lowering LDL cholesterol and a treatment for advanced cancers will have shortened review times.
read more
The Japan-based company will acquire Radicava ORS and IV Radicava along with a subsidiary in the U.S.
read more
The new nod makes Aqvesme the only FDA-approved drug for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.
read more
BHV-7000 also fell short in a phase 3 bipolar mania trial back in March.
read more
The agency has set a PDUFA target action date of April 30, 2026 for the oral NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor.
read more
Three clinical trials on patients with histories of motion sickness showed that the treatment significantly reduced vomiting compared with a placebo.
read more
Although the drug met its primary endpoint in a clinical trial, the FDA wants additional proof of effectiveness.
read more
The oral medication was approved in December based on phase 3 trial results that showed an average weight loss of 17%.
read more
Lilly will pick up clinical stage NLRP3 inhibitors in an all-cash $1.2 billion deal.
read more