On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its ...

In the ever shifting theatre of global militancy, women are no longer just sitting in the wings, but have, unfortunately, ...

The agency previously declined to approve Atara's first Ebvallo biologics license application, but has accepted a data package it resubmitted this month.

Vinay Prasad exits FDA's biologics division following pressure over Sarepta's Elevidys approval and regulatory controversies.

Sette added that like rodents, cockroaches produce important allergens, particularly in under-resourced urban settings.

As Baloch insurgents escalate deadly attacks on Pakistani forces and inflict casualties, Army Chief Asim Munir has blamed ...

The FDA has accepted for priority review the resubmitted BLA for tabelecleucel to treat patients 2 years of age and older with EBV+ PTLD who have received at least 1 prior therapy.

Qure advances its pathology-shifting AMT-130 therapy for Huntington's disease; pivotal data and commercial launch prep target 2025 milestones.

Global regulatory advancements in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases ...

As of June 30, 2025, the Company had cash, cash equivalents and investment securities of $377.0 million. The Company expects that cash, cash equivalents and investment securities will be sufficient to ...

HC Wainwright initiates Ultragenyx at Buy with $80 target, citing strong rare disease pipeline and late-stage data expected ...

Vera Therapeutics' Phase 3 data on atacicept sparks optimism for IgAN treatment, but competition and market challenges may ...