Lupin receives approval from USFDA for Pirfenidone tablets
This product will be manufactured at Lupin’s Pithampur facility in India
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USFDA
US FDA places partial clinical hold on Gilead’s studies on Magrolimab for AML treatment
The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk…
Lupin gets US FDA nod for Bromfenac Ophthalmic Solution, 0.09%; Metoprolol Succinate ER Tablets USP
Both products will be manufactured at Lupin’s Pithampur facility in India
Sigachi Industries forays into API business, acquires majority stake in Trimax Bio Sciences
The API unit is approved by USFDA for advanced and critical intermediates
Granules Pharma completes USFDA PADE Inspection with zero observations
The inspection was conducted at Granules Pharmaceuticals from July 31, 2023 to August 03, 2023
Zydus gets USFDA approval for Indomethacin suppository with CGT designation
The company has been granted 180-day CGT exclusivity to market this product
Lupin gets US FDA approval for Norgestrel and Ethinyl Estradiol Tablets USP
This product will be manufactured at Lupin’s Pithampur facility in India.
Pharma industry headwinds in remission: ICRA
Revenues of ICRA’s sample set to grow by 7-9 per cent in FY2024; OPM to stabilise at 20.5-21.5 per cent in FY2024
USFDA approves Sanofi-AstraZeneca’s preventive RSV therapy for babies
The companies plan to make Beyfortus available in the United States ahead of the upcoming RSV season, Sanofi said, adding that it…
BridgeBio Pharma’s heart disease drug meets main goal in late-stage study
The company said no safety concerns were identified in patients, adding that it intends t submit marketing applications to the US…