Eugia's East Windsor facility gets 10 observations from USFDA
The plant is yet to start commercial operations
The plant is yet to start commercial operations
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Studies have demonstrated that ZYIL1 is highly potent and can suppress inflammation caused by NLRP3 inflammasome activation
Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus
Lacosamide is indicated to treat partial-onset seizures
Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cell
The product will be manufactured at Lupin's Pithampur facility in India
Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
The CVMP recommends the product for approval for the treatment and persistent killing of fleas
Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product
This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa
The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million
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