On June 30, 2026, the U.S. Department of Health and Human Services (HHS) announced that COVID-19 Emergency Use Authorization (EUA) declarations will terminate on December 26, 2026, for medical devices and on June 29, 2027, for drugs and biological products.
On July 22, 2026, the SEC approved Nasdaq’s proposal (Release No. 34-105971) to adopt a new continued listing requirement based on Market Value of Listed Securities (“MVLS”). Under new Nasdaq Rules 5450(a)(3) and 5550(a)(6), companies listed on the
On July 23, 2026, the SEC announced that it will host a public roundtable on September 17, 2026, to discuss preparations for potential 24-hour trading in the U.S. equity markets. The roundtable will focus on overnight trading infrastructure, market operations
Formycon AG (“Formycon”) announced its partnership with OneSource Specialty Pharma Limited (“One Source”) on July 14, 2026. OneSource, located in Bangalore, India, will complement Formycon’s biosimilar development experience with its biologics manufacturing capabilities. OneSource has an integrated biologics platform that
On July 9, 2026, Teva Pharmaceutical Industries and Samsung Bioepis announced they have entered into a license and commercialization agreement for OPUVIZ® (aflibercept), Samsung Bioepis’s biosimilar referencing Regeneron’s EYLEA®, in Canada. Under the agreement, Samsung Bioepis will remain responsible for
On July 9, 2026, Accord BioPharma announced that the FDA approved ENNUMO (pegfilgrastim-pccg). ENNUMO references Amgen’s NEULASTA (pegfilgrastim). The FDA approved ENNUMO on May 7, 2026, for the same indications as NEULASTA: for adult and pediatric patients, to decrease the
On July 9, 2026, Teva Pharmaceuticals International GmbH (“Teva”) and Polpharma Biologics International AG (“Polpharma Biologics”) announced a global licensing agreement under which Teva will obtain exclusive rights to commercialize Polpharma Biologics’ proposed biosimilar to Genentech’s OCREVUS (ocrelizumab), including both
On July 1, 2026, Harrow announced the commercial launch of BYOOVIZ (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab). BYOOVIZ was developed by Samsung Bioepis Co., Ltd. (“Samsung Bioepis”).
BYOOVIZ was originally launched in the United States by Biogen in 2022.
The Texas Stock Exchange (TXSE) commenced quoting and trading securities pursuant to unlisted trading privileges on July 6, 2026, and the new national securities exchange intends to commence trading of other securities on the exchange in the coming weeks. The
