The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure
Under this agreement, lpca will grant to Omexa a non-exclusive right to research, develop, manufacture and market an anti-cancer biosimilar for the global market
Oscotec has successfully completed phase 2 study in patients with chronic ITP last year
To accelerate the development of next-generation radioconjugates to treat cancer
Additional capacity broadens Grace’s fine chemical capabilities for API production
New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day
Strategic multi-year research collaboration to identify novel targets with strong disease links and to accelerate clinical development
Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS
The U.S. FDA recently approved Xolair as the first and only medicine for children and adults with one or more food allergies
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