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A daily, curated feed of drug and pharmaceutical news. FDA actions, approvals, recalls, shortages, and the companies behind them.
BioPharma DiveSep 18, 2026
Xenon shares fall following depression trial pause
The occurrence of “neuropsychiatric” adverse events in testing fueled investor doubts about a drug the FDA is already reviewing for a form of epilepsy.
Read at BioPharma Dive →BioPharma DiveSep 18, 2026
Ultragenyx prices Sanfilippo gene therapy at $4M; Bristol Myers shelves Orum drug
Ultragenyx’s second gene therapy approval since August gives it another sellable voucher. Elsewhere, Roche declared success in a blood cancer trial and a cell therapy maker is cutting costs.
Read at BioPharma Dive →STAT — PharmaSep 18, 2026
STAT+: Roche expands its Boston footprint with new research center
A gene therapy approved for Sanfilippo syndrome, good and bad news for Xenon Pharma, and more biotech news
Read at STAT — Pharma →
STAT — PharmaSep 18, 2026
STAT+: Up and down the ladder: The latest comings and goings
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Read at STAT — Pharma →
STAT — PharmaSep 18, 2026
STAT+: Pharmalittle: We’re reading about licensing deals with China, making drugs in space, and more
The U.S. is working on rules for investing in China that would likely preserve pharma's ability to strike most licensing deals for Chinese drugs
Read at STAT — Pharma →
STAT — PharmaSep 17, 2026
Kennedy renews attacks on vaccines at Children’s Health Defense conference
Health secretary RFK Jr. returned to his roots in a keynote address at a conference hosted by the Children’s Health Defense, an anti-vaccine nonprofit he helped start.
Read at STAT — Pharma →
FDA — Press ReleasesSep 17, 2026
FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A.
Read at FDA — Press Releases →BioPharma DiveSep 17, 2026
Novo partners with Orbis, deepening investment in oral peptide drugs
The potentially $1.4 billion alliance will see the two companies collaborate on “macrocycles” that could yield oral treatments for cardiometabolic diseases.
Read at BioPharma Dive →STAT — PharmaSep 17, 2026
STAT+: New startup to test psychedelic-like drug against Parkinson’s symptom
A psychedelic-like drug for a Parkinson's symptom, mice with half-human brains, and more biotech news in the Readout newsletter.
Read at STAT — Pharma →
STAT — PharmaSep 17, 2026
STAT+: FDA has too few staffers to hire more staff
FDA's hiring bottleneck, Dems plan for health care oversight, and more from STAT's D.C. Diagnosis newsletter.
Read at STAT — Pharma →
BioPharma DiveSep 16, 2026
Novo looks to Anthropic’s AI models to ‘supercharge’ drug development
The Danish drugmaker will use Claude Science as part of a goal to become "the world’s most AI-driven healthcare company."
Read at BioPharma Dive →BioPharma DiveSep 16, 2026
Sling banks $123M for an experimental thyroid eye disease pill
A confirmatory late-stage study is now also underway for what the startup is positioning as, potentially, the first oral alternative to approved injectables like Amgen's Tepezza and Viridian's Lumvoa.
Read at BioPharma Dive →STAT — PharmaSep 16, 2026
STAT+: Sen. Warren demands to see Trump drug-pricing pharma contracts, accuses RFK Jr. of hiding them
An FDA pilot program to speed up drug development, Democrats plan health care probes after midterms, and more biotech news
Read at STAT — Pharma →
STAT — PharmaSep 16, 2026
STAT+: Pharmalittle: We’re reading about faster FDA approvals, access to experimental drugs in Montana, and more
The FDA is opening applications for a pilot program designed to shorten the time it takes for drugmakers to begin testing their products in humans
Read at STAT — Pharma →BioPharma DiveSep 16, 2026
Skyhawk racks up more support for Huntington’s drug
The Fidelity-backed biotech now has 15-month data from a small study of its RNA-splicing therapy.
Read at BioPharma Dive →BioPharma DiveSep 15, 2026
FDA clears first generic radioligand drug; Sionna turns to layoffs
A Lutathera copycat has become the first “radioligand equivalent” cleared by regulators. Elsewhere, Novo dropped the “Nordisk” from its name and a novel RNAi drug showed early promise.
Read at BioPharma Dive →BioPharma DiveSep 15, 2026
WCLC ‘26: A new ‘ADC era,’ China questions and AstraZeneca’s spotlight
The year’s biggest meeting on lung cancer research featured data suggesting a new treatment standard for an aggressive tumor as well as debate about the reliability of results from China-run studies.
Read at BioPharma Dive →STAT — PharmaSep 15, 2026
STAT+: FDA takes applications for new program to shorten drug approval times
The FDA is opening applications for a pilot program designed to shorten drug approval timelines and help the U.S. compete with countries like China and Australia.
Read at STAT — Pharma →
BioPharma DiveSep 15, 2026
FDA launches pilot program to speed up early US drug research
First teased in June and formally announced Tuesday as part of “Operation Trialblazer,” the program will partner drugmakers with research institutions to more quickly bring medicines into human testing.
Read at BioPharma Dive →FDA — Press ReleasesSep 15, 2026
FDA Launches Expedited IND Pilot, Begins Accepting Applications
The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot.
Read at FDA — Press Releases →BioPharma DiveSep 14, 2026
Summit, Akeso look to shed PD-1/VEGF drug doubts with latest study results
As dueling data emerge between their drug ivonescimab and a rival Merck medication, Summit and Akeso revealed new findings that impressed Wall Street.
Read at BioPharma Dive →BioPharma DiveSep 14, 2026
AstraZeneca’s newly approved pill fails frontline breast cancer study
Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
Read at BioPharma Dive →BioPharma DiveSep 14, 2026
Cellectis quits CAR-T and pivots to ‘in vivo’ gene editing
Long a frontrunner in donor-derived cell therapy research, the French biotech cited a shifting landscape in changing course and choosing to offload its lead programs.
Read at BioPharma Dive →STAT — PharmaSep 14, 2026
STAT+: GSK touts lung cancer data from two drugs
Late-stage results for Definium's LSD treatment, AstraZeneca breast cancer drug fails key trial, and more biotech news from The Readout
Read at STAT — Pharma →
STAT — PharmaSep 14, 2026
STAT+: Pharmalittle: We’re reading about another AstraZeneca trial failure, a Novo name change, and more
AstraZeneca disclosed that a breast cancer pill failed in a pivotal trial testing it as a first-line therapy in advanced tumors
Read at STAT — Pharma →STAT — PharmaSep 13, 2026
STAT+: Trump’s secretive pharma deals may undermine ‘most-favored nation’ pricing, an analysis suggests
The projected savings from Trump's "most-favored nation" pricing policy might be drastically reduced by secretive deals with pharma companies, a new analysis finds.
Read at STAT — Pharma →
STAT — PharmaSep 12, 2026
STAT+: Breast cancer pill from AstraZeneca misses mark in pivotal trial
A pill from AstraZeneca failed to improve outcomes in closely watched breast cancer study, a result that could limit the use of the medicine.
Read at STAT — Pharma →
STAT — PharmaSep 11, 2026
STAT+: Pharma wins a battle over the cost of wastewater treatment in Europe
An E.U. AG recommended annulling part of a directive that requires drugmakers to finance 80% of the costs of wastewater treatment.
Read at STAT — Pharma →
STAT — PharmaSep 11, 2026
STAT+: Up and down the ladder: The latest comings and goings
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
Read at STAT — Pharma →STAT — PharmaSep 11, 2026
STAT+: Pharmalittle: We’re reading about anxious Novartis investors, patent expirations for biologics, and more
Novartis investors are stepping up scrutiny of the company's dealmaking after setbacks to drugs it acquired through mergers and acquisitions
Read at STAT — Pharma →STAT — PharmaSep 11, 2026
STAT+: Cancer drug shortages keep disrupting patient care
Platinum chemotherapy's long-term effects, surprising heart failure drug failures, and more biotech news from The Readout
Read at STAT — Pharma →
BioPharma DiveSep 11, 2026
Karyopharm pushes off debt payment; Amgen eyes broader Imdelltra use
Karyopharm bought an extra month to negotiate with creditors or pursue a deal. Elsewhere, BridgeBio Pharma’s oncology spinout shook up its development plans and a brain-focused gene therapy startup banked $275 million.
Read at BioPharma Dive →STAT — PharmaSep 10, 2026
STAT+: The gifts from pharma companies that keep on giving
There has been rancorous debate over doctors accepting free gifts and speaking fees from pharma companies. That doesn't mean doctors have reconsidered.
Read at STAT — Pharma →
BioPharma DiveSep 10, 2026
FDA places partial hold on Biohaven’s epilepsy drug
Announced mere weeks after Biohaven sold off rights to the therapy, opakalim, the halt affects a study some analysts believe is necessary to support a potential approval.
Read at BioPharma Dive →STAT — PharmaSep 10, 2026
STAT+: FDA expands Bayer lung cancer drug approval
UniQure readout tests durability of benefits, an AI effort to manage heart failure, and more biotech news from The Readout
Read at STAT — Pharma →
STAT — PharmaSep 10, 2026
STAT+: Cancer medicines remain in short supply across the U.S., survey finds
An ongoing shortage of cancer medications continues to force leading cancer centers around the U.S. to seek work-around strategies to treat patients and a majority also report that clinical trials…
Read at STAT — Pharma →BioPharma DiveSep 9, 2026
FDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders
After almost two years of turnover in the FDA’s top ranks, the new appointments should help ease concerns about more turmoil ahead, one analyst said.
Read at BioPharma Dive →STAT — PharmaSep 9, 2026
STAT+: Orexin discoverers awarded prestigious Lasker award
A new FDA CBER head, AI company Schrodinger with a new startup, and more biotech news from The Readout
Read at STAT — Pharma →
STAT — PharmaSep 9, 2026
STAT+: Pharmalittle: We’re reading about an AstraZeneca COPD win, the FDA filling key jobs, and more
An AstraZeneca drug reduced the dangerous flare-ups that worsen COPD in a pair of late-stage trials
Read at STAT — Pharma →BioPharma DiveSep 9, 2026
A new immuno-oncology play raises $225M for a next-generation drug
Solstice Oncology is advancing a medicine from China’s Harbour BioMed that it believes is able to address the weaknesses of drugs aimed at CTLA-4, a popular but tricky cancer immunotherapy target.
Read at BioPharma Dive →STAT — PharmaSep 8, 2026
STAT+: FDA names acting heads of drug and vaccine centers to permanent roles
The moves bring stability to an agency that's been rocked by the exits of top leadership.
Read at STAT — Pharma →
BioPharma DiveSep 8, 2026
Roivant surges on ‘exceptional’ results; Bristol Myers touts first-of-its-kind CAR-T therapy
One analyst views Roivant’s pulmonary hypertension drug as a future $10 billion-plus seller. Elsewhere, AstraZeneca overcame a negative advisory committee vote and Pharvaris claimed success in a key study.
Read at BioPharma Dive →STAT — PharmaSep 8, 2026
STAT+: FDA warns an API supplier about residue on walls, a corroded product line, and open-toed sandals
The FDA warned a supplier of active pharma ingredients about residue on walls, a corroded product line, and open-toed sandals at its facility. It also included photos.
Read at STAT — Pharma →
BioPharma DiveSep 8, 2026
Moonwalk reloads with $70M and new RNAi prospects for obesity
The California biotech plans to bring its first drug, enabled by licensing technology from a Chinese drugmaker, into clinical testing for obesity by the end of 2027.
Read at BioPharma Dive →STAT — PharmaSep 8, 2026
STAT+: Oura files to goes public, reported $1.2B in earnings
In health tech news today, Oura reports a profit, the FDA loses another key digital health leader, and more
Read at STAT — Pharma →
STAT — PharmaSep 8, 2026
STAT+: FDA approves AstraZeneca breast cancer drug
Roivant drug delivers mid-stage results, Moonwalk raises funds to develop longer-lasting obesity drugs, and more biotech news
Read at STAT — Pharma →STAT — PharmaSep 8, 2026
STAT+: Pharmalittle: We’re reading about another Novartis trial failure, a Novo Nordisk setback, and more
An experimental Novartis drug for a rare neuromuscular condition failed to improve muscle function in a pivotal study
Read at STAT — Pharma →STAT — PharmaSep 8, 2026
STAT+: AstraZeneca’s experimental COPD treatment posts strong results in late-stage studies
An experimental COPD drug from AstraZeneca could prove competitive with existing treatments, and have a slice of the market to itself.
Read at STAT — Pharma →
STAT — PharmaSep 8, 2026
STAT+: Neuromuscular drug from Novartis fails in key study, adding to pressure on company
A Novartis drug for a rare neuromuscular condition failed in a key study, the company's second major trial collapse in a matter of days.
Read at STAT — Pharma →
STAT — PharmaSep 7, 2026
STAT+: Novo Nordisk stops two cardiovascular trials of drug aimed at lowering inflammation
Novo Nordisk has stopped two trials of a drug that aims to tame inflammation as a way to improve cardiovascular health, another blow for the approach.
Read at STAT — Pharma →
BioPharma DiveSep 5, 2026
Novartis, Ionis drug failure spurs questions about an emerging class of heart medicines
Pelacarsen didn’t protect heart health despite lowering levels of a protein particle, “Lp(a),” in a large clinical trial — a surprise result with important implications for cardiovascular drug research.
Read at BioPharma Dive →STAT — PharmaSep 4, 2026
STAT+: Novartis’ experimental cardiovascular drug fails a pivotal study
A closely watched cardiovascular drug from Novartis failed in a pivotal study, the company said Friday, a major blow to the firm.
Read at STAT — Pharma →
FDA — Press ReleasesSep 4, 2026
FDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN)
Read at FDA — Press Releases →FDA — Press ReleasesSep 4, 2026
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
Read at FDA — Press Releases →BioPharma DiveSep 4, 2026
Trailing rivals, AbbVie scores win with dual-acting myeloma drug
The drugmaker is leaning on a better side effect profile compared to drugs from J&J, Pfizer and Regeneron as it pushes etentamig toward FDA submission.
Read at BioPharma Dive →STAT — PharmaSep 4, 2026
STAT+: FDA takes another look at botanical drugs
The biggest barrier for a top schzophrenia treatment, Ionis' first approval for Alexander disease, and more biotech news
Read at STAT — Pharma →
STAT — PharmaSep 4, 2026
STAT+: We’re reading about a Bristol CAR-T trial pause, Pfizer offloading a shelved candidate, and more
The latest pharma news from the Pharmalot campus brought to you by the Pharmalittle newsletter
Read at STAT — Pharma →
BioPharma DiveSep 4, 2026
Ionis’ rare neurology drug approved; Pfizer inks an ADC deal
Zanvastro is now the first approved medicine for Alexander disease. Elsewhere, an immune system specialist posted positive results and a cell therapy developer turned to layoffs.
Read at BioPharma Dive →STAT — PharmaSep 3, 2026
STAT+: Ionis wins FDA approval for first drug for Alexander disease, a rare and deadly neurological disorder
Zanvastro is the first disease-modifying treatment for Alexander disease, a rare and fatal disorder.
Read at STAT — Pharma →
FDA — Press ReleasesSep 3, 2026
FDA Approves First Drug to Treat Alexander Disease
The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.
Read at FDA — Press Releases →Sources: reputable US pharmaceutical news outlets and FDA press releases, via their public feeds. Links open the publisher's site and carry no endorsement. Pillstats is a referrer, not a republisher.