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Voydeya approved in the EU as add-on treatment to ravulizumab
News | April 23, 2024

Voydeya approved in the EU as add-on treatment to ravulizumab

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


Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines
Drug Approval | April 23, 2024

Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines

Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies


Boehringer Ingelheim introduces NexGard Spectra for dogs in India
News | April 22, 2024

Boehringer Ingelheim introduces NexGard Spectra for dogs in India

NexGard Spectra is a soft, flavourful monthly chew that kills fleas before they can lay eggs


Orexo extends patent protection for its nasal epinephrine powder product OX640 in the US
News | April 22, 2024

Orexo extends patent protection for its nasal epinephrine powder product OX640 in the US

The newly issued patent, US Patent No. 11,957,647, provides both expanded scope of protection as well as longer patent term


Akums launches Bharosa campaign
News | April 22, 2024

Akums launches Bharosa campaign

The campaign marks an important milestone in its journey within the pharmaceutical manufacturing industry


Biocon inks agreement for Ozempic commercialization in Brazil with Biomm
News | April 19, 2024

Biocon inks agreement for Ozempic commercialization in Brazil with Biomm

Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market


Positive data for Roche multiple sclerosis injection
Drug Approval | April 17, 2024

Positive data for Roche multiple sclerosis injection

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


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