EU MDR, FDA, CE Regulations

SHERIDAN, WYOMING – July 29, 2025 – In a swift regulatory reversal, the U.S. Food and Drug Administration (FDA) has lifted its recommendation for a voluntary hold on Sarepta Therapeutics’ gene therapy Elevidys for ambulatory Duchenne muscular dystrophy (DMD) patients—restoring immediate commercial viability for the treatment and stabilizing investor confidence after weeks of uncertainty.

FDA Reinstates Ambulatory Access Following Brief Hold

SHERIDAN, WYOMING – July 29, 2025 – The American Medical Association (AMA) has issued a public plea urging Health Secretary Robert F. Kennedy Jr. to preserve the U.S. Preventive Services Task Force (USPSTF), following reports that the panel could be dissolved due to ideological concerns. The potential shakeup, while not yet finalized, has sparked widespread concern across the healthcare community and could significantly impact access to preventive care services nationwide.

SHERIDAN, WYOMING – July 29, 2025 – Sarepta Therapeutics is once again under regulatory spotlight following the death of an 8-year-old boy in Brazil who had received its gene therapy Elevidys, triggering an FDA investigation and fresh market turbulence for the embattled biotech.

SHERIDAN, WYOMING – July 25, 2025 – Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx). The application sought approval for this regimen as a second-line treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.

SHERIDAN, WYOMING – July 25, 2025 – As Q2 2025 earnings season unfolds, leading biotech firms face scrutiny amid a backdrop of regulatory headwinds, clinical trial disruptions, and evolving commercial strategies. Several key players are poised to reveal performance metrics that could reshape market sentiment across the pharmaceutical innovation landscape.

Sarepta Faces Scrutiny Amid Safety Setbacks and Strategic Pivot

SHERIDAN, WYOMING – July 25, 2025 – The U.S. Food and Drug Administration (FDA) has cast doubt over GSK’s attempt to return its antibody-drug conjugate Blenrep to the U.S. market for relapsed or refractory multiple myeloma, citing persistent safety concerns and limited evidence of efficacy across key patient populations.

SHERIDAN, WYOMING – July 25, 2025 – Roche has received CE Mark certification for its Elecsys® pTau181 blood test, marking a pivotal advancement in Alzheimer’s diagnostics by introducing the first IVDR-certified in-vitro diagnostic test to help rule out Alzheimer’s-associated amyloid pathology.

SHERIDAN, WYOMING – July 21, 2025 – Sarepta Therapeutics has entered a critical phase of uncertainty after reports surfaced that the U.S. Food and Drug Administration (FDA) is considering requesting a halt to all shipments of its Duchenne muscular dystrophy (DMD) gene therapy, Elevidys. The potential move follows the disclosure of a third patient death associated with the company's underlying gene therapy platform.

FDA Scrutiny Intensifies After Third Death Linked to Platform

SHERIDAN, WYOMING – July 21, 2025 – GlaxoSmithKline’s ambitions to relaunch its antibody-drug conjugate Blenrep for multiple myeloma treatment faced a critical blow last Thursday, as the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) rejected two proposed combination therapies over persistent safety and dosing concerns.

Safety Risks and Dosing Shortfalls Undermine Confidence

SHERIDAN, WYOMING – July 12, 2025 – A landmark release of 200 complete response letters (CRLs) by the U.S. Food and Drug Administration (FDA) has unveiled a decade of regulatory decisions behind once-rejected therapies, now approved and on the market. Among the most revealing cases are Eli Lilly’s Alzheimer’s treatment Kisunla, Sarepta’s Duchenne muscular dystrophy drug Vyondys 53, and Gilead’s long-acting HIV therapy Sunlenca.