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Fresenius Kabi USA flies complaint against NATCO Pharma
News | April 19, 2024

Fresenius Kabi USA flies complaint against NATCO Pharma

Natco Pharma intends to defend the matter accordingly


Jubilant Pharmova’s Roorkee unit gets VAI status
Drug Approval | April 18, 2024

Jubilant Pharmova’s Roorkee unit gets VAI status

FDA has concluded that this inspection is 'closed'


Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution
Drug Approval | April 17, 2024

Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers


GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Drug Approval | April 17, 2024

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met


USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria
News | April 17, 2024

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections


AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer
Diagnostic Center | April 17, 2024

AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer

Longest survival follow-up ever reported for immunotherapy treatment in this setting


Alvotech and Teva get US FDA approval of Selarsdi
Drug Approval | April 17, 2024

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva


Laurus Labs forms JV company
News | April 16, 2024

Laurus Labs forms JV company

KRKA holds 51% and Laurus Labs holds 49% shareholding


Moderna pauses plan to build mRNA manufacturing facility in Kenya
News | April 16, 2024

Moderna pauses plan to build mRNA manufacturing facility in Kenya

The demand in Africa for COVID-19 vaccines has declined


Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
Drug Approval | April 14, 2024

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.