Drug Approval | March 11, 2022
USFDA approves Lupin’s Vigabatrin oral solution
The product will be manufactured at Lupin’s facility in Goa, India
The product will be manufactured at Lupin’s facility in Goa, India
Breakthrough formulation helps reduce the risk of exposure using a non-hazardous formulation and leakproof format during transport and processing
The studies demonstrate a standardized strategy to extend mechanistic modeling and systems pharmacology into drug safety and mode of action assessments that has relevance for drug development and a variety of other contexts
Nulibry is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder
Alvotech expects AVT02 (adalimumab) will be marketed in the U.S., subject to regulatory approval, on July 1, 2023
New results build on previously reported significant recurrence-free survival (rfs) benefit seen in these patients
The company is investing up to US $ 500 million to produce up to 500 million doses each year for the African continent
Nystatin and Triamcinolone Acetonide ointment is indicated for the treatment of cutaneous candidiasis
Toyobo will start looking at ways to use the knowhow from DMC’s sophisticated fermentation process technologies to enhance the efficiency of making its bioproducts
This supply agreement provides material for the company’s planned 30-patient pilot study, and later for its planned U.S. pivotal study in spine fusion patients
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