The FDA has granted accelerated approval to Ultragenyx Pharmaceutical's GENGLYCOS gene therapy for treating glycogen storage disease type Ia in patients eight years and older. This marks the first FDA-approved treatment for this rare genetic disorder that prevents the liver from properly releasing glucose, requiring patients to maintain frequent raw cornstarch intake and strict dietary monitoring.

Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis...

Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations...

On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon's candidate biosimilar to Regeneron's EYLEA® (aflibercept).

Formycon recently announced its sales and earnings figures for the first quarter of 2022. Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million),...

On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis...

On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation.

On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny).

Incyte has entered into a definitive agreement to acquire Vega Therapeutics for $1.25 billion upfront, with potential milestone payments reaching up to $2.0 billion total.

On May 2, 2022, the ITC instituted an investigation of Hugel's botulinum toxin product based on a complaint filed by Medytox on March 30, 2022.

On March 14, 2022, Prestige BioPharma Ltd., a Singapore-based biopharmaceutical company, announced positive safety and efficacy results in a Phase III study ("TROIKA") for HD201

On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin's biosimilar of Certolizumab Pegol across multiple global markets.

On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR).

On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech's AVASTIN.

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen's STELARA...

Samsung Bioepis launches OPUVIZ aflibercept biosimilar in Europe, Amneal and Kashiv challenge Novartis omalizumab patent, EMA recommends two ranibizumab biosimilars, Eli Lilly acquires three vaccine companies...

Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen's bone cancer drug XGEVA...

On May 20, 2024, Teva Pharmaceuticals ("Teva") and Alvotech announced the availability of SIMLANDI (adalimumab-ryvk) injection in the United States, for the treatment of adult rheumatoid arthritis...

Alvotech and Teva announced an expansion of their existing strategic partnership agreement relating to biosimilars products in the U.S.

Teva Pharmaceuticals and Polpharma Biologics have entered into a global licensing agreement for the commercialization of a biosimilar candidate to Genentech's OCREVUS (ocrelizumab), a treatment for multiple sclerosis. The agreement combines Polpharma Biologics' development expertise with Teva's commercial capabilities across major markets including the United States, Europe, and several other territories. Under the terms, Polpharma Biologics will handle development and manufacturing while Teva manages regul