Drug Approval | August 12, 2025
Boehringer’s lung cancer medicine gets FDA approval
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle
NorUDCA is the first?in?class treatment for Non?alcoholic Fatty Liver Disease (NAFLD) in India
Prucalopride is prescribed for chronic idiopathic constipation
The submission is supported by positive results from the Phase 3 AMPLIFY trial
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
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