Regulatory

The vaccine advisory committee’s meeting has yet to be rescheduled.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

HHS Secretary Robert F. Kennedy Jr. reorganized senior leadership at the department to streamline management and advance the administration’s health policy priorities.

The new once-monthly dosing schedule for Rybrevant Faspro in combination with Lazcluze offers a more convenient option and also maintains efficacy and safety comparable to the prior bi-weekly regimen.

Without new legislation, pilot programs, or years of rulemaking, the agency could use enforcement discretion to create a fast, risk-based pathway for low-risk early-stage trials.

The letter follows Phase II data that did not sufficiently link biomarker reductions to clinical benefit.

Eli Lilly's $1.5 billion pre-launch inventory of orforglipron signals an aggressive manufacturing strategy aimed at avoiding supply shortages and capturing early share in the competitive obesity market.

The withdrawal is due to data shared from FDA reflecting that data included in the NDA submission is unlikely to meet the required threshold of evidence.

The approval of Keytruda (pembrolizumab) and Keytruda Qlex was supported by Phase III KEYNOTE-B96 data showing statistically significant improvements in progression-free and overall survival in patients with PD-L1–positive platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma.

A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing partnerships to sustain momentum in its respiratory franchise.

Hims & Hers moved to remove access to its compounded semaglutide offering following mounting regulatory scrutiny and legal pressure from Novo Nordisk.

TrumpRx is meant to reduce drug costs, but Americans are wondering how it works and what impact it will have.

FDA Commissioner Marty Makary’s warning against mass-marketed copycat drugs escalated the regulatory and legal clash over compounded oral GLP-1 products.

The site offers users coupons for a limited number of medications that can be redeemed at pharmacies and/or manufacturer DTC sites.

The approval is for a new formulation of the medication that allows for it be provided as an oral film.

FDA’s complete response letter for subcutaneous Saphnelo highlights regulatory scrutiny around manufacturing and formulation changes in the industry.

FDA PreCheck will provide benefits to manufacturing sites that fit criteria focused on benefiting the United States.

How demand-driven development will help new products be more successful.

The preservative, which contains a form of Mercury, has long been the target of anti-vaccine groups, despite studies demonstrating its safety.

The FDA's approval is based on results from the Phase III CEPHEUS study, showing deeper and more durable responses compared with standard therapy.

When researchers excluded studies that did not use proper methods to collect data, the results showed no connection between the medication and genetic disorder.

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health.

FDA approval of Vanda’s Nereus marks a rare and meaningful regulatory milestone, introducing the first new pharmacologic option for motion sickness in decades and underscoring renewed innovation in a long-neglected but widely impactful condition.

The approval marks the first agency-cleared oral formulation of a GLP-1 drug for obesity.