Drug Approval | April 28, 2024
Zydus receives final approval from USFDA for Tretinoin Cream
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV
Sales reflect continued strong growth in oncology and vaccines
ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue
Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US
NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
Breakthrough Therapy designation for pain associated with DPN granted by FDA
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