Category Press Releases

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the…

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Novartis presents new long-term Leqvio® (inclisiran) data demonstrating consistent efficacy and safety beyond six years

Novartis today announced new long-term data from ORION-8, a Phase III open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3 trials. The data demonstrated that with twice-yearly* dosing, Leqvio, in addition…

Read MoreNovartis presents new long-term Leqvio® (inclisiran) data demonstrating consistent efficacy and safety beyond six years

Sandoz completes acquisition of leading antifungal agent Mycamine® from Astellas, reinforcing leading global anti-infectives portfolio

Sandoz, a global leader in generic and biosimilar medicines, has successfully completed the acquisition of worldwide brand rights for leading systemic antifungal agent Mycamine ® (micafungin sodium, Funguard® in Japan) from Astellas. Through…

Read MoreSandoz completes acquisition of leading antifungal agent Mycamine® from Astellas, reinforcing leading global anti-infectives portfolio

Novartis issues EGM Invitation and Shareholder Information Brochure. Sandoz publishes Listing Prospectus ahead of proposed Spin-off vote

Novartis today issued the invitation to an Extraordinary General Meeting (EGM) of Novartis shareholders, scheduled to take place on September 15, 2023, in relation to the proposed 100% Spin-off of…

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U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for…

Read MoreU.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age

Novartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria

Novartis today announced positive top-line results from the Phase III REMIX-1 and REMIX-2 studies evaluating remibrutinib 25 mg b.i.d., a Bruton’s tyrosine kinase (BTK) inhibitor, in patients with chronic spontaneous…

Read MoreNovartis remibrutinib Phase III trials met their primary endpoints and showed rapid symptom control in chronic spontaneous urticaria