Regulatory

Since the start of President Trump's second term, the FDA, CDC, CDER, and CBER have collectively cycled through more than a dozen leadership changes.

ADVI’s head of market access policy strategy discusses how the Trump administration’s efforts.

FDA has approved Foundayo, Eli Lilly's once-daily oral GLP-1 receptor agonist, as the first small molecule pill of its kind for obesity.

Approval of Biogen's high-dose Spinraza strengthens the company’s lifecycle strategy in SMA, enhancing durability while reinforcing competitive positioning in a rapidly evolving neurology market.

Kresladi becomes the first FDA-approved gene therapy for children with severe LAD-I due to biallelic variants in ITGB2, and Awiqli the first and only once-weekly basal insulin treatment for adults with type 2 diabetes.

The White House postponed naming a permanent CDC director as the Trump administration navigates competing political pressures ahead of midterm elections.

FDA has granted accelerated approval to Avlayah, the first therapy engineered to cross the blood-brain barrier and treat the neurological manifestations of Hunter syndrome.

This is the agency's first approved treatment for acquired hypothalamic obesity.

FDA has approved Wegovy HD, a higher-dose 7.2 mg injectable semaglutide, based on Phase III data showing a mean weight loss of 20.7% in adults with obesity.

FDA has approved Icotyde as the first oral targeted therapy for moderate-to-severe plaque psoriasis, offering adults and adolescents a once-daily pill that blocks the IL-23 receptor.

The ruling places a hold on any decisions made by the council, although the government does plan to appeal the ruling.

Arexvy is now approved for adults aged 18 to 49 with underlying conditions that elevate their risk of severe RSV disease.

FDA cites systemic failures in how the company tracked and reported adverse drug events across several of its medicines, including semaglutide.

Europe’s Joint Clinical Assessment promises harmonization, but it introduces a new layer of strategic complexity that manufacturers must navigate at both EU and national levels.

Ron Wyden led 7 Democrats demanding details from Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly.

FDA approved GSK's Wellcovorin as the first treatment for cerebral folate deficiency caused by a rare genetic variant.

The application is based on Phase III trial data showing the drug reduced the risk of invasive disease recurrence or death.

The vaccine chief briefly left the role last summer before almost immediately returning to it.

FDA informed uniQure it will not accept external control data as the primary basis for approving AMT-130, instead demanding a prospective, randomized, sham surgery-controlled trial before moving forward.

Alice Valder Curran discusses how the industry continues to strategize around this complicated order.

Defining the “active ingredient” is the central challenge of biologic PTE, because biologics are large, complex molecules that do not fit neatly into a statutory framework built for small molecule drugs.

FDA approves a supplemental BLA for BioMarin Pharmaceutical Inc.’s Palynziq, expanding its use to adolescents 12 and older with PKU.

FDA expands approval of Novo Nordisk’s once-weekly Sogroya to include three new pediatric growth disorder indications, offering children as young as 2.5 an alternative to daily growth hormone injections backed by Phase III non-inferiority data.

FDA grants accelerated approval to Boehringer Ingelheim’s Hernexeos (zongertinib) for treatment-naïve HER2-mutant advanced NSCLC.

The approval makes Dupixent the first FDA-approved therapy for allergic fungal rhinosinusitis, supported by Phase III data showing significant improvements in sinus opacification, nasal symptoms, and reductions in surgery and systemic corticosteroid use.