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Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration.

On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application ("sBLA") for Dupixent (dupilumab)...

On February 8, 2023, Regeneron announced that the FDA approved its EYLEA® (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants

On October 20, 2025, the FDA approved Genentech's GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN).

On October 27, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI (toripalimab-tpzi)...

Explore the latest regulatory approvals, biosimilar launches, and patent settlements shaping the biologics market. From FDA approvals of groundbreaking gene therapies to strategic acquisitions and BPCIA litigation updates, discover how innovation and competition are transforming treatment access across oncology, immunology, and rare diseases.

In a recent publication we helped co-author, we examined ClinicalTrials.gov entries and their possible impact on informing potential subjects of their eligibility to participate in clinical trials.

This month, Genentech announced a voluntary recall of the ranibizumab injection (SUSVIMO) ocular implant and associated insertion tool. SUSVIMO, which provides continuous administration of the anti-VEGF...

In October, NORD will also hold its annual Breakthrough Summit in Washington, DC on October 20-22, 2024. This event draws over 1,000 attendees including patients/caregivers...

Explore the latest developments in biosimilar approvals, regulatory updates, and strategic acquisitions shaping the pharmaceutical landscape.

On July 20, 2023, Sandoz announced that it plans to invest approximately $90 million to build a Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026.

Health experts say making HRA Pharma's Opill pill available without a prescription will prevent more unwanted pregnancies, and the need for abortions.

On April 10, 2023, Celltrion confirmed the bioequivalence of CT-P39 to treat allergic asthma and chronic urticaria, through its interim results from its global phase 3 clinical trials at 24 weeks.

Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy's Laboratories ("DRL") and Fresenius Kabi.

On March 19, 2022, the parties in the Amgen Inc. v. Hospira Inc. (D. Del., No. 20-201) NEULASTA®/pegfilgrastim litigation submitted a stipulation to dismiss all claims and counterclaims...

Allen Smith, Managing Partner, Mohari Hospitality

Approval of Celltrion's Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43...