The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
The company had earlier announced about the approval received from the MHRA for Liraglutide
For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure
First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus
USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+
WINREVAIR is a breakthrough biologic for this rare, progressive disease
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
Centhaquine is a resuscitative agent presently indicated for the treatment of hypovolemic shock by DGCI
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024
A five-day inspection was concluded successfully with no critical and no major observations raised
Winlevi is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
The company is confident of addressing the concern raised by the USFDA
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
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