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.
Baxfendy reduces systolic blood pressure by inhibiting the production of the hormone aldosterone, lowering the risk for heart and kidney problems.
read more
Kissei Pharmaceutical has issued a safety alert regarding Tavneos.
read more
The new identity is not the result of an acquisition or merger; it is a strategic step that consolidates the company's operations under one brand.
read more
Acting directors of CDER and CBER are both leaving their roles.
read more
The company offers a natural colorant portfolio, produced via fermentation of baker's yeast.
read more
The LRRK2 inhibitor failed to slow the progression of idiopathic Parkinson’s disease and didn't meet any of the phase 2 trial’s secondary endpoints.
read more
The agency is extending the PDUFA date for the company’s camizestrant combination, citing a need to review additional data to support the NDA.
read more
The deal centers around Edgewise’s sevasemten, an investigative orally administered first-in-class fast skeletal myosin inhibitor.
read more
Compared to the standard of care, the therapy led to a progression-free survival of 18 months vs. 8.3 months.
read more
Between exposure and day 10, the drug reduced the risk of symptomatic COVID by 67%.
read more
Rezdiffra is the first approved oral treatment for metabolic dysfunction-associated steatohepatitis in both the U.S. and UK.
read more
The letter did not raise any concerns regarding the clinical safety or efficacy of CTx-1301.
read more
In a phase 3 trial, the drug met its primary endpoint and showed a safety profile consistent with that observed in adults.
read more
Lilly shared phase 3 data for its once-daily GLP-1 tablet, Foundayo, across a broader set of patient populations than its approved obesity indication.
read more
The Boston biotech has two oral kinase inhibitors already under FDA review.
read more