Drug Approval | 06 June 2024
Shilpa Biologicals files Type IV DMF of recombinant Human Albumin 20% with USFDA
This novel recombinant has been developed and is a patented novel recombinant Human Albumin 20% process
This novel recombinant has been developed and is a patented novel recombinant Human Albumin 20% process
Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson’s disease
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death
Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation
Theophylline is used to treat asthma and chronic obstructive pulmonary disease
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Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection
The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States
According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)
Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
The company is committed to address this observation comprehensively within stipulated time
The product is used to treat amyotrophic lateral sclerosis
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms
With this, for all our USFDA facilities, EIRs are in place
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