FDA Drug Approvals 2026 Surge as Launch Prices Top $257,000

A crowded approval year runs into a pricing problem

The U.S. Food and Drug Administration is having a busy 2026. New medicines have been approved for obesity, rare genetic disorders, and many kinds of cancer. Over the same weeks, the economics behind those approvals have come under heavy criticism. A report released October 20 by the Institute for Clinical and Economic Review (ICER) and West Health found that the median net launch price of a new drug rose 35% between 2022 and 2025 after adjusting for inflation, from about $190,000 to $257,000 a year.19 So the system is getting new medicines approved faster while the bill for them keeps growing.

The main point of this article is that the FDA's pace and the industry's prices are no longer separate stories. Cancer drugs feature heavily in both. The agency is shortening review times for some oncology products, and the policy tools meant to restrain prices have so far had little effect on what new drugs cost when they first reach the market.

How many drugs, exactly?

Trackers disagree on how many novel drugs have been approved, mostly because they use different cutoff dates and counting methods. One tracker based on the FDA's own list counted 29 novel approvals from the Center for Drug Evaluation and Research as of July 24.3 Another had reached 33 by mid-August.6 A third site that follows the agency's listings showed 46 novel approvals by mid-October, with the most recent being Hovilpri (pritelivir), approved October 9 for drug-resistant herpes simplex lesions in immunocompromised adults.7 One trade publication described the third quarter as the busiest of the year so far, with 22 new therapies.4 An article from July that put the full-year figure at 23 was clearly out of date soon after it ran.10

The exact numbers vary, but the trend is clear. Approvals picked up after a slow January, reached about six in March, and kept building through the summer.5 A rough count of more than 40 novel drugs by late October puts 2026 on track for a strong year, though not a record one.

Several approvals were firsts for their class. Eli Lilly's Foundayo (orforglipron) was approved April 1 as the first once-daily oral small-molecule GLP-1 drug for obesity, with no food or water restrictions on when to take it.8 Pfizer and Arvinas' Veppanu (vepdegestrant) became the first approved PROTAC, a type of drug that breaks down its target protein, for ESR1-mutated breast cancer.5 Novo Nordisk's Awiqli became the first once-weekly basal insulin. Orzeyful (oveporexton) is the first drug to treat the orexin deficiency that causes narcolepsy type 1, rather than just its symptoms.6

Cancer remains the center of gravity

Cancer treatment has been the largest single group of 2026 approvals, both for brand-new drugs and for new uses of existing ones. Among novel drugs, the list includes:

• Lifyorli (relacorilant) for platinum-resistant ovarian cancer
• Beqalzi (sonrotoclax) for relapsed mantle cell lymphoma
• Revtorpyk (gedatolisib) for HR+/HER2-, PIK3CA wild-type breast cancer
• Jideytro (zidesamtinib) for ROS1-positive lung cancer513
• Rasonque (daraxonrasib), Revolution Medicines' drug for metastatic pancreatic cancer, approved August 26
• Etcamah (camizestrant), AstraZeneca's drug for ESR1-mutated breast cancer, approved September 47

Zenbexus (iberdomide) for multiple myeloma and Tudriqev, Replimune's oncolytic virus for advanced melanoma, both received accelerated approval in August.1

October has added more new uses for existing cancer drugs:

• Jaypirca (pirtobrutinib): cleared for previously untreated chronic lymphocytic leukemia on October 2.2
• Tukysa (tucatinib): approved as part of a maintenance regimen for HER2-positive breast cancer on October 7. In the supporting trial, median progression-free survival rose from 16.3 to 24.9 months.
• Tecentriq (atezolizumab): approved with chemotherapy for stage III mismatch repair-deficient colon cancer after the ATOMIC trial showed a disease-free survival hazard ratio of 0.50, meaning roughly half the risk of recurrence or death.25

The most notable recent decision came on October 19. The FDA granted accelerated approval to GSK's Jemperli (dostarlimab) for stage II/III rectal cancer that is MSI-H or dMMR, two related tumor markers.22 In the main AZUR-1 study, 71% of 154 patients were treated with dostarlimab alone and needed no further therapy without their disease progressing.21 A smaller study led by outside investigators reported a 93% rate of complete response sustained for 12 months.21 GSK said the drug could let eligible patients skip chemotherapy, radiation, and surgery. It is the first immunotherapy approved specifically for this type of rectal cancer, which makes up 5% to 10% of rectal tumors.26

The way this approval was handled matters as much as the result. The FDA reviewed the application under the Commissioner's National Priority Review Voucher pilot and its Real-Time Oncology Review program, and approved it four months ahead of its target date.22 Because it is an accelerated approval, the indication could be withdrawn if confirmatory trials do not show clinical benefit.26 The agency is clearly willing to approve early when the response data are strong. Whether patients can get these drugs quickly is a different question, and it depends on price.

The price side of the ledger

Coverage of the ICER report agrees on its main findings. About one in four drugs launched in 2025 carried an annual net price above $500,000, and another 34% were priced between $200,000 and $500,000.1912 Only about a third of the newly approved drugs ICER had reviewed were priced at or below its cost-effectiveness benchmark.19 Even after accounting for drug features such as orphan status, the median net launch price still rose about 18% a year.12

A separate study in JAMA by Harvard Medical School researchers, which looked at list prices rather than net prices, reached a similar conclusion. It found that the median price of a new drug rose from about $39,000 in 2008 to more than $250,000 in 2025, roughly 16% a year.14 Two research groups using different data and methods ended up with nearly the same figure, which makes the trend hard to dismiss as an artifact of one method.

The breakdown for cancer drugs is less obvious than the headline numbers suggest. According to figures from the ICER report circulated by a coalition critical of the industry, median net launch prices for cancer drugs rose only 3% from 2022 to 2025, to about $387,000. Prices for non-cancer drugs nearly tripled, to about $197,000.17 Cancer drugs started out expensive and have stayed there. Most of the recent growth has come from other areas, such as small-molecule drugs, whose median more than doubled.17 Individual cancer launches still set records: Rasonque launched at about $480,000 a year, one of several cancer drugs since 2024 priced above $400,000.14

Access, not just sticker shock

The ICER report also shows how high prices affect patients. Only about a third of outpatient prescriptions for new drugs were filled within 30 days, and many rejections stemmed from insurers declining to cover drugs new to the market.18 One summary found that four in ten prescriptions for the reviewed drugs were rejected, with higher rejection rates for Medicare patients.16 The West Health–Gallup Center found that nearly 40% of Americans were worried about paying for prescriptions in the coming year, up from 25% in 2022.18

The industry rejects the report's framing. PhRMA called ICER's methodology flawed and argued that overall drug prices have been flat or falling. The group did agree that coverage denials and administrative hurdles are limiting patient access.12 PhRMA has also said list prices give a misleading picture because the prices actually negotiated are often much lower.14 That argument is weaker against the ICER report, which measures net prices after rebates.19

Policy hasn't touched launch prices yet

The JAMA study found that the Inflation Reduction Act did not change the path of launch prices. Medicare's negotiating power is limited to a small number of older drugs: small-molecule drugs become eligible after seven years on the market and biologics after eleven.14 The Trump administration's "most favored nation" deals aim to keep U.S. launch prices in line with those in other wealthy countries. However, most terms of those deals are confidential, and critics expect companies to respond by launching later abroad.12 A new Medicare pricing rule finalized September 30 will apply to just four companies, and the government now estimates it will save $440 million over seven years, compared with almost $12 billion projected in the proposed version.14

The incentives point in one direction. Axios reported ICER's suggestion that drugmakers may be setting high launch prices to earn as much as possible before future government negotiations cut into revenue.12 When negotiation applies only years after launch, the launch price is the part of a drug's life that companies control most, and the evidence suggests they are using that control.

The 2026 approvals include real advances, from an oral obesity pill to a rectal cancer treatment that can spare patients surgery. They are also arriving under a pricing system that neither the IRA nor the most-favored-nation deals have yet changed. The next test of that system is the expected FDA decision on Novo Nordisk's CagriSema later this year.9