XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

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FDA Approval Bacteria Trials Protein 95

XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. Both next-gen shots offer enhanced protection against bacteria that can cause pneumonia, blood infections and meningitis.

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FDA Approval Vaccination Vaccine Immune Response 89

XTalks

MAY 17, 2024

The settlement requires Totality to take several specific corrective actions, which include refraining from making any statements that suggest the spa’s products are genuine, FDA-approved Lilly products, and stopping the use of Eli Lilly branding in promoting any of the products.

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Sales FDA Approval Pharmacy Production 52

Pharmaceutical Technology

OCTOBER 28, 2022

The company says that these four serotypes represent roughly 10–15% of bacteria causing pneumococcal disease in adults. While the first pneumococcal polysaccharide vaccine was approved in the US in 1977, the first conjugate shot Prevnar was greenlighted only in 2000. VAX-24 has forecasted sales of $21 million in the same year.

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Vaccination Vaccine Marketing Bacteria 162

XTalks

JUNE 1, 2022

BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market. Osteomyelitis is a bone infection caused by fungi or bacteria. What was special about this latest FDA approval from the company’s (BONESUPPORT’s) commercial perspective?

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Filler FDA Approval Production Marketing 98

pharmaphorum

JULY 2, 2021

Under the terms of the new deal, Nestle’s Health Sciences unit will pay Seres another $125 million if the FDA approves the drug – called SER-109 – and is also line for up to $225 million in commercial milestones tied to sales targets. diff infection. diff, which can germinate and grow after the course is completed.

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Bacterium Drugs Bacteria FDA Approval 69

pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). If approved, SER-109 would be the first-ever FDA-approved oral microbiome therapeutic.

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Bacteria FDA Approval Licensing Licensing 45