Pharminent

FDA grants Jemperli accelerated approval in locally advanced rectal cancer

The FDA granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) in patients with MSI-H/dMMR locally advanced rectal cancer, a use that may allow some patients to avoid chemotherapy, radiation and surgery.

FDA approves Roche’s Enspryng for thyroid eye disease

The FDA approved Roche’s Enspryng in thyroid eye disease, a second indication for the drug. Enspryng is the first drug suitable for at-home administration in TED.

FDA finalizes guidance on biosimilar postapproval manufacturing changes

On October 13, 2026, the FDA announced a final guidance for industry titled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers,” finalizing a draft of the same title issued on July 23, 2024.

Trump orders new NIH women’s health division and task force

President Trump signed an executive order creating a women’s health division at the NIH along with a task force, a research and policy initiative that Melania Trump said will set “a new standard for women’s health.”

Disc Medicine reports Phase 3 success for bitopertin in EPP

Disc Medicine said its APOLLO Phase 3 trial of bitopertin in erythropoietic protoporphyria succeeded, and the company plans to re-engage regulators after the FDA rejected the treatment.

Merck KGaA to acquire Silence Therapeutics for $1.3B

Merck KGaA agreed to acquire UK-based Silence Therapeutics in a deal valued at $1.3 billion, adding the siRNA therapy divesiran, which has passed a Phase 2 test in the blood disorder polycythemia vera.

Roche signs ADC deal with Hansoh worth up to $15B

Roche entered a collaboration and license agreement with Hansoh Pharma covering a broad portfolio of antibody-drug conjugates, paying $400 million up front in a deal that could be worth more than $15 billion.

Teva and Samsung Bioepis expand biosimilar partnership to six candidates

Teva and Samsung Bioepis announced on October 1, 2026 a new global license, development and commercialization agreement covering up to six potential biosimilar candidates, with Samsung Bioepis responsible for development, regulatory registration and manufacturing.

AstraZeneca and Oracle launch AI platform for clinical trials

AstraZeneca launched a project with Oracle to use AI and real-world data to improve clinical research and patient care.

China proposes restrictions on foreign biotech acquisitions

China is proposing new restrictions on foreign acquisitions of critical biopharmaceutical technologies as it seeks to retain control over its drug development industry.

Analysis finds median net launch price of new medicines at $257,000

An analysis of 202 newly launched medicines found the median net price rose 35% to $257,000 last year from $173,000 in 2022.