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Majority of children with spinal muscular atrophy treated with Evrysdi (risdiplam) are able to sit, stand and walk independently, two-year data demonstrate – Genentech/Roche

Written by | 21 Oct 2024

Genentech, a member of the Roche Group  presented positive 2-year data from the ongoing RAINBOWFISH study at the 29th World Muscle Society (WMS) Congress, October 8-12, 2024, assessing… read more.

Updated 2024-2025 Nuvaxovid COVID-19 Vaccine (NVX-CoV2705) receives authorization in the EU – Novavax

Written by | 20 Oct 2024

9 October 2024-Novavax, Inc. announced that the European Commission granted Marketing Authorization for Novavax’s updated 2024-2025 Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in… read more.

Application submitted for third indication of darolutamide in the EU – Bayer

Written by | 19 Oct 2024

Bayer announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer is seeking approval for the use… read more.

FDA approves Hympavzi for the treatment of adults and adolescents with hemophilia A or B without inhibitors – Pfizer

Written by | 18 Oct 2024

Pfizer Inc. announced  that the FDA has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12… read more.

FDA approval for 320 mg single-injection device presentations of Bimzelx – UCB

Written by | 17 Oct 2024

UCB  announced that the FDA has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx (bimekizumab-bkzx). These new device presentations add to… read more.

Talzenna (talazoparib) + Xtandi (enzalutamide) prolongs overall survival in phase III TALAPRO-2 trial for prostate cancer

Written by | 16 Oct 2024

Pfizer Inc. announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna  (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor,… read more.

Johnson & Johnson extended filing at EMA for Darzalex (daratumumab subcutaneous) + R-VDd for newly diagnosed multiple myeloma

Written by | 15 Oct 2024

Janssen-Cilag International NV, a Johnson & Johnson company,  announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication… read more.

FDA approves Flyrcado (flurpiridaz F 18) radioactive diagnostic for enhanced diagnosis of coronary artery disease

Written by | 14 Oct 2024

GE HealthCare  announced that the FDA has granted approval of Flyrcado (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI)… read more.

Novaliq + Laboratoires Théa announce partnership and EU approval for Vevizye for dry eye disease

Written by | 13 Oct 2024

Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol water-free technology, and Laboratoires Théa (Théa), the leading independent eye care group… read more.

Positive data for Arexvy, respiratory syncytial virus vaccine, indicating protection over three RSV seasons – GSK

Written by | 12 Oct 2024

GSK plc announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine,… read more.

Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life

Written by | 11 Oct 2024

Medtronic plc, a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed 600 series or 700… read more.

Airsupra demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA phase III trial

Written by | 10 Oct 2024

Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s Airsupra (albuterol/budesonide) met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk… read more.

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