Welcome to Fierce Pharma's regulatory tracker for the second 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, July 7 at 10:15 a.m. ET
AbbVie and Genmab's CD20xCD3 bispecific Tepkinly, known as Epkinly in the U.S., has won European Commission approval for use in combination with lenalidomide and rituximab in previously treated follicular lymphoma (FL).
The EU approval follows an FDA nod for the same indication in November 2025. The green light is based on results from the phase 3 Epcore FL-1 trial, which showed that the combination reduced the risk of progression or death by 79% versus lenalidomide-rituximab alone.
FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL). As the second most common form of NHL, FL accounts for 20% to 30% of all NHL cases, with higher incidence rate in European populations (11%-29%) versus non-European populations (2%-18%), according to AbbVie.
UPDATED: Monday, July 06 at 10:45 a.m. ET
With several years passed since the end of the COVID-19 pandemic, Robert F. Kennedy Jr.’s Department of Health and Human Services has nixed the emergency use authorizations (EUAs) that remain for several drugs, biological products and medical devices, determining that “the circumstances that justified these emergency authorities no longer exist.”
“By ending these COVID-19 emergency use authorization declarations, we're reinforcing public confidence that emergency authorities are temporary and targeted,” Kennedy said in a statement posted to the HHS’ website last week.
Many well-known COVID-19 vaccines and treatments, from Pfizer and BioNTech’s vaccine Comirnaty to the antivirals Paxlovid and Gilead’s Veklury, possess traditional, full approvals from the FDA, while other products like Merck & Co.’s Lagevrio (molnupiravir) still hold EUAs dating from the pandemic.
In justifying its decision in a Federal Register notice, the HHS argued that reliance on authorized drugs and biological products has waned, with other vaccines, convalescent plasma products and therapeutics for all age groups and spectrum of disease now approved through traditional pathways.
The termination of the EUAs for drugs and biological products will take effect in a year.
At least one drugmaker, Invivyd—whose authorized prophylactic antibody Pemgarda (pemivibart) has been caught in the crossfire—suggested that it is in dialogue with the FDA about next steps for its product. That said, “to date, neither HHS nor FDA has expressly provided Invivyd with such written advice regarding a Pemgarda regulatory approval pathway,” the company explained in a release Monday.
Nevertheless, the “end of a formal emergency for COVID products is in many ways overdue,” Marc Elia, Invivyd’s board chairman, said in a statement.
He continued: “At Invivyd, we believe Pemgarda has sufficient clinical and post-authorization data to support Biologics License Application (BLA) submission and approval, and we regret that procedural uncertainty has needlessly intruded into our work on behalf of vulnerable Americans, who may find these headlines worrying and confusing.”
UPDATED: Wednesday, July 1 at 2:00 p.m. ET
The FDA has assigned a target decision date of Feb. 28, 2027, for Sarepta Therapeutics’ applications that seek to convert the accelerated approvals of Amondys 45 and Vyondys 53 to full approvals.
Sarepta filed the two exon-skipping drugs for the treatment of Duchenne muscular dystrophy (DMD) despite missing the primary endpoint of a confirmatory trial called Essence. The company has pointed to an average 0.05 steps/second difference in favor of the therapies on a 4-step ascend velocity test designed to measure DMD patient mobility, as well as real-world evidence, to support its case. It has also suggested that the COVID-19 pandemic confounded the Essence readout.
“In populations this small and in a disease where damage unfolds over years, real-world experience is essential to understanding how these therapies impact the disease course,” Louise Rodino‑Klapac, Ph.D., Sarepta’s president of research & development and technical operations, said in a June 30 statement. “We look forward to working with the FDA throughout the review.”
In a Tuesday note, Jefferies analysts estimated that investors are assuming a 50%-plus probability of approval. The analysts suggested that the FDA may allow the two drugs to remain in the market even if the agency declined to convert the accelerated approvals.