New hope could be on the horizon for ALS patients in the form of a “breakthrough" drug, researchers say. Neuvivo is seeking ...
GlobalData on MSN3d
Intercept’s liver disease drug Ocaliva faces FDA approval delayAn FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...
The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...
Learn how to effectively navigate the challenges of CMC in breakthrough drug development. Discover key strategies here.
In its new drug application, Stealth BioTherapeutics described elamipretide as a first-in-class mitochondrial protective ...
GlobalData on MSN4d
Avadel wins FDA approval for narcolepsy drug Lumryz in childrenThe expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...
Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. But with ...
Pharmaceutical Technology on MSN7d
Bayer applies for EU approval of menopause drug elinzanetantBayer notches up pressure on rival Astellas’ Veozah with an EU marketing authorisation application for its hot flash relief ...
Diet and diabetes drugs like Ozempic and Mounjaro could also help people struggling with alcohol and opioid abuse, according ...
AI-based clinical simulation systems can be a game-changer for the pharmaceutical industry. The ability to predict clinical ...
ADRX-0405 is a novel antibody-drug conjugate targeting STEAP1, and a phase 1a/b study will investigate the agent for the ...
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