Market Access

Fosun Debuts da Vinci 5 in China at 9th CIIE, Touts 65 GMP Sites

HONG KONG – November 05, 2026 -- Fosun has used its ninth consecutive China International Import Expo (CIIE) appearance to debut Intuitive Surgical's da Vinci 5 robotic system in China. It also reported that its Intuitive Fosun joint venture has trained more than 23,000 doctors across 33 training centers. This year's expo in Shanghai draws participants from 162 countries, regions and international organizations, with more than 4,100 corporate exhibitors.

Fosun is exhibiting at the Fosun Pharma booth (2.1C4-01) in the Medical Equipment and Healthcare Products Exhibition Area. Its displays cover oncology, immunology and inflammation, and neurodegenerative diseases. Fosun International Chairman Guo Guangchang described the CIIE as "an annual test of our global industrial and innovation capabilities."

IASO Bio Launches FUCASO CAR-T in Singapore, Wins Reimbursement

Shanghai – November 03, 2026 -- IASO Bio's FUCASO, the first BCMA-targeted CAR-T therapy approved in Singapore, will be covered under the country's Cancer Drug List (CDL) from December 1, 2026. The coverage follows the product's commercial launch in Singapore on November 3 with local partner Pills and Pokes.

Singapore's HSA approved FUCASO in June 2026 for late-line multiple myeloma

The Health Sciences Authority cleared FUCASO for adults with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three prior lines of therapy. Those lines must include at least one proteasome inhibitor and one immunomodulatory agent. IASO Bio describes the product as the world's first fully human BCMA-targeted CAR-T therapy.

Lupin Launches Generic Raltegravir in US, Gains 180-Day Exclusivity

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Lupin Launches Generic Raltegravir in US, Gains 180-Day Exclusivity

MUMBAI – – November 03, 2026 -- Lupin Limited has launched Raltegravir Tablets USP, 600 mg in the United States and is eligible for 180-day generic drug exclusivity, after the U.S. FDA approved its Abbreviated New Drug Application.

The product is bioequivalent to the reference listed drug Isentress HD Tablets, 600 mg, marketed by Merck Sharp & Dohme, LLC. Lupin is the exclusive first-to-file applicant for the product.

Reference product generated an estimated USD 26 million in annual US sales

Isentress HD 600 mg had estimated annual U.S. sales of USD 26 million, according to IQVIA MAT September 2026 data. That figure is the market the 180-day exclusivity window covers for Lupin.

Nanoscope Fields Four Executives at Advanced Therapies USA 2026

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Nanoscope Fields Four Executives at Advanced Therapies USA 2026

DALLAS – October 29, 2026 -- Nanoscope Therapeutics will field four executives across six sessions at Advanced Therapies USA 2026 in Boston on November 4-5, as its optogenetic gene therapy MOGENRY (sonpiretigene isteparvovec; MCO-010) awaits decisions from the U.S. FDA and Japan's PMDA. The conference, held at the Hynes Convention Center, brings together cell and gene therapy developers, manufacturers, investors and commercial leaders.

SetPoint Medical Treats First Boston Patient With RA Nerve Implant

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SetPoint Medical Treats First Boston Patient With RA Nerve Implant

Santa Clarita – October 29, 2026 -- SetPoint Medical has treated its first patient in Boston with the SetPoint System, extending the only FDA-approved neuroimmune modulation therapy for rheumatoid arthritis (RA) to adults across New England.

Beth Israel Deaconess surgeon performs first Boston implant

Joshua P. Aronson, M.D., a functional neurosurgeon at Beth Israel Deaconess Medical Center (BIDMC), performed the procedure. He described it as an outpatient intervention that opens a different treatment pathway for RA patients.

The system includes a small implantable neurostimulator that delivers targeted stimulation to the left vagus nerve. The stimulation activates the body's innate anti-inflammatory pathways to regulate the immune activity associated with RA.

CMS Moves to Quarterly HCPCS Drug Code Cycles, Semi-Annual for Devices

United States – October 25, 2026 -- The Centers for Medicare & Medicaid Services (CMS) will replace its single annual window for HCPCS Level II code applications with quarterly cycles for drugs and semi-annual cycles for devices, Administrator Seema Verma said at the Medical Device Manufacturers Association (MDMA) Annual Meeting.

CMS expects faster adoption for new technologies under the revised coding calendar

Until now, applicants for new HCPCS Level II codes had one opportunity per year. CMS anticipates the more frequent windows will greatly improve how technologies move through the adoption curve. The agency said additional details on the updated process will follow.

Cboe Extends Options Trading Hours on 29 Stocks and ETFs

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Cboe Extends Options Trading Hours on 29 Stocks and ETFs

Chicago – October 19, 2026 -- Cboe Global Markets launched pre- and post-market trading in options on 24 single stocks and 5 ETFs on its Cboe Options Exchange (C1). Options on these names accounted for roughly 53% of average daily U.S.-listed options volume in 2026 through September.

Cboe opens two new sessions for equity and ETF options on C1

The pre-market session runs from 7:30 a.m. to 9:25 a.m. ET and the post-market session from 4:00 p.m. to 4:15 p.m. ET, Monday to Friday. C1 is currently the only U.S. options exchange offering pre- and post-market index options sessions. It is now extending extended-hours access to select single-stock and ETF options.

The covered underlyings include AAPL, AMZN, GOOG, GOOGL, META, MSFT, NVDA, TSLA and PLTR. The ETFs are SPY, QQQ, IWM, GLD and XLF. Cboe describes the group as including the Magnificent 10 stocks.

SciBase wins first US payer coverage for Nevisense via Highmark

Stockholm – October 14, 2026 -- SciBase Holding AB (STO: SCIB) has received its first positive medical policy for Nevisense from Highmark Blue Cross Blue Shield, which serves more than 7 million members across multiple US states. The decision moves eligible use of the skin-lesion device from a predominantly cash-pay model into covered care through a major private insurer.

Highmark policy applies to all commercial lines and opt-in self-funded groups

Highmark considers electrical impedance spectroscopy (EIS) medically necessary when a dermatologist is evaluating a clinically atypical suspicious pigmented lesion and is considering a biopsy. The procedure is reported under CPT code 0658T. The policy covers all Highmark commercial insured lines of business and self-funded (ASO) employer groups that elect it.

Coverage is limited to defined cases:

Highlander Silver Wins NYSE American Approval, Trading March 11

Toronto – October 12, 2026 -- Highlander Silver Corp. has received approval to list its common shares on the NYSE American LLC, with trading expected to begin Wednesday, March 11, 2026, under the symbol "HSLV."

The company will keep its existing Toronto Stock Exchange listing under the same ticker, giving it a dual-listed structure across Canadian and U.S. exchanges.

Highlander Silver holds assets in Peru and Mexico

The company is advancing a portfolio in Peru that includes the San Luis gold-silver project and the Corani silver project. It also operates the Mercedes gold-silver mine in Mexico.

According to S&P Global rankings cited by the company, San Luis ranks among the 10 highest-grade projects globally in both the gold and silver categories.

Zydus, MSN Launch First Generic Riociguat in U.S. Market

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Zydus, MSN Launch First Generic Riociguat in U.S. Market

Ahmedabad – – October 05, 2026 -- Zydus Lifesciences Limited, in partnership with MSN Laboratories Private Limited, has launched the first generic version of riociguat in the United States, undercutting a branded drug whose maker, Bayer, reported approximately EUR 745 million (roughly USD 850 million) in global sales for 2025.

FDA clears five generic strengths matching Adempas

The U.S. Food and Drug Administration approved Riociguat Tablets in 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg doses as generic equivalents of Bayer's Adempas Tablets across all strengths. MSN developed and manufactures the product, while Zydus handles U.S. commercialization.