US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
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This facility manufactures APIs & formulations of oncology and non-oncology products.
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
The company will respond to the Warning Letter within the stipulated timelines
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
The Product is expected to be the first generic approval on the market
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial
Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers
The approval marks a significant milestone for the American pharmaceutical company in the field of UC
TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery
This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia
Application based on results from the TROPION-Breast01 Phase III trial
Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux
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
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