FDA grants Imara a rare pediatric disease designation for IMR-687, the companys lead product candidate for treating sickle cell disease.
FDA accepts for review an Aerie Pharmaceuticals NDA for Rhopressa (netarsudil ophthalmic solution) 0.02%, indicated for treating elevated intraocular ...
CDER officials say expanded access decisions have not led to a negative regulatory decision regarding a drug application.
FDA issues a Form 483 to Badrivishal Chemicals & Pharmaceuticals (Maharashtra, India) related to a 8/2016 facility inspection that cited significant G...
Federal Register notice: FDA announces the availability of a guidance for industry on Three-Month Extension of Certain Tobacco Product Compliance Dead...
Senators Amy Klobuchar (D-MN), John McCain (R-AZ), and Chuck Grassley (R-IA) urge the Trump Administration to use existing executive authority to lowe...
Eli Lilly says it will file a BLA in the second half of this year after reporting positive Phase 3 data involving galcanezumab, an investigational tre...
FDA clears a Quidel 510(k) to market its Solana C. difficile Assay for the direct, qualitative detection of the Clostridium difficile DNA in unformed ...