Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Be sure to come back regularly for the latest updates.
UPDATED: Tuesday, January 6 at 11:15 a.m. ET
GSK's Exdensur has been endorsed in Japan as a treatment for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), making it the first ultra-long-acting biologic in the country in the two indications.
Japan's Ministry of Health, Labour and Welfare approved the drug for severe or refractory patients with asthma whose symptoms cannot be controlled with existing treatments and for patients with CRSwNP whose disease is inadequately controlled with standard treatment.
GSK's Swift and Anchor phase 3 studies supported the approval, GSK said in a press release. The trials showed that twice-yearly doses of the drug plus standard of care resulted in significant reductions in asthma exacerbations and nasal polyp size and nasal obstruction in the respective indications compared with placebo and standard of care.
The Japan nod comes amid a regulatory winning streak for the medicine, which recently picked up approvals in the U.S. and U.K.
UPDATED: Monday, January 5 at 9:05 a.m. ET
China's National Medical Products Administration (NMPA) has approved GSK's Nucala as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) whose condition is characterized by raised blood eosinophils.
With the approval, Nucala becomes the first monthly biologic in the country for a large proportion of patients with inadequately controlled COPD, GSK said in a Jan. 5 release. The nod covers patients with blood eosinophil counts (BEC) as low as 150 cells/µL.
The approval was based on data from GSK's MATINEE and METREX phase 3 studies. In the trials, Nucala showed its ability to reduce the rate of moderate/severe COPD exacerbations versus placebo and standard of care in a "wide spectrum" of COPD patients with an eosinophilic phenotype, GSK said.
Roughly 100 million people in China have COPD, the company said. Deaths from COPD in the country represent nearly a third of all COPD deaths worldwide, according to the drugmaker.
"The approval of Nucala offers patients in China a monthly add-on maintenance treatment to reduce exacerbations, including those leading to emergency department visits and/or hospitalisations which account for a large proportion of annual direct medical costs," Kaivan Khavandi, GSK's global head of respiratory, immunology and inflammation R&D, said in a statement.
UPDATED: Friday, January 2 at 9:40 a.m. ET
After receiving prior FDA rejections in 2023 and mid-2025, Outlook Therapeutics capped off the year by announcing that ONS-5010 had been turned away by the U.S. regulator once again.
In a Dec. 31 announcement, the company said the FDA spurned Outlook's Biologics License Application resubmission based on a lack of confirmatory evidence.
ONS-5010, also known as Lytenava, is an ophthalmic reformulation of bevacizumab, a cancer drug from Roche that has long been used off-label as a treatment for wet age-related macular degeneration (wet AMD).
In its Complete Response Letter, the FDA cited an ongoing need for "confirmatory evidence of efficacy," the company said, caveating that the agency "has not indicated what type of confirmatory evidence would be acceptable."
After the FDA rejected Outlook's prior filing last summer, the company resubmitted its application in November with data from its Norse clinical trial program. The company contends its data package "provides the required evidence to support approval of the ONS-5010" in the U.S.
Before the latest round of regulatory interactions, the FDA rejected the drug back in 2023 over manufacturing and data shortfalls. In Europe, officials approved the drug last year as a treatment for wet AMD.
Before the U.S. market opened on Friday, Outlook's stock was trading down about 61% to 61 cents per share.