Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
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
Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
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
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