FDA approves Sun Pharma's Vobrig, a leuprolide acetate injection
The new drug application for Vobrig, a subcutaneous leuprolide acetate solution, received FDA approval with a status date of August 26, 2026.
Drugs@FDA
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Tuesday, September 15
Friday, September 11
Sun Pharma gets labeling supplement approved for carbidopa and levodopa tablets
Strides Pharma gets manufacturing supplement approved for polyethylene glycol 3350
Wednesday, September 2
Sun Pharma gets FDA labeling supplement approval for oxcarbazepine oral suspension
Wednesday, August 26
Tuesday, August 25
Sun Pharm gets manufacturing supplement approval for tadalafil ANDA covering four tablet strengths
Friday, August 14
Sun Pharma logs eleven FDA labeling supplements and two REMS updates in one week
Thursday, August 6
Zentalis reports Q2 2026 results as DENALI Part 2 nears full enrollment
The company said its accelerated approval strategy for azenosertib remains intact after FDA discussions, with topline DENALI Part 2 data expected in 1H 2027.
Drugs@FDA, SEC filing (2)