Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi ® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli ® (pegcetacoplan) ...

On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care ...

Pfizer Inc. today announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide ...

Analysis of the open label data from FLAMINGO-01 has commenced and has been conducted in a manner that maintains the study blind. A preliminary review of FLAMINGO-01 HLA data in both the HLA-A*02 ...

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It was a busy week for the biotech sector as the fourth-quarter earnings season kicked in. While Regeneron REGN gained following the announcement, Amgen AMGN was in the red. Meanwhile, other pipeline ...

Investigational Review Board (IRB) approval has been granted for the open-label study to evaluate tafenoquine for treatment of patients with a presumptive diagnosis of chronic babesiosis in ...

Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change ...

Zoetis has updated the US label for Librela (bedinvetmab injection), following ... event signs have been reported at a rate higher than “rare” under European Medicines Agency (EMA) standards, with ...

Carlos Alcaraz believes Jannik Sinner is the "best right now" after his "crazy" form continued with victory at the Australian Open. World No. 1 Sinner swept to a second straight win in Melbourne ...

Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental ...

Greenwich LifeSciences, Inc. announced progress in its Phase III clinical trial FLAMINGO-01, which is studying its immunotherapy GLSI-100 to prevent breast cancer recurrences. The European ...