Sign inThe agency's records list a new pembrolizumab-chemotherapy approval in biliary tract cancer, alongside earlier belzutifan and pembrolizumab decisions in kidney cancer and TMB-H tumors.
FDA (5)
A record notice: the source is linked, and no summary was written because none passed the fact check.
FDA
The FDA has approved updated safety labeling addressing dihydropyrimidine dehydrogenase (DPD) deficiency for fluorouracil injection products.
FDA
The approval covers neoadjuvant chemotherapy plus durvalumab followed by adjuvant single-agent durvalumab after surgery.
FDA
A separate FDA notice shows zanubrutinib, sold as Brukinsa, was approved January 19, 2023 for chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA (2)
The FDA has cleared elranatamab-bcmm for multiple myeloma under its accelerated approval pathway, according to the agency's own posting.
FDA
The company said a supplemental BLA remains on track for year-end 2026 submission, with Q3 net product revenue up 53% to $48.7 million.
FDA, SEC filing (3)
Mirum Pharmaceuticals disclosed topline results and new long-term data on the investigational antibody, with a BLA submission planned for early 2027.
SEC filing
Fate said Phase 1 data presented at ASN Kidney Week showed full renal response in the bendamustine cohort informing its RECLAIM-LN Phase 2 study, while FT839 sites begin activating.
FDA, SEC filing (3)
The agency cleared Kisqali with an aromatase inhibitor and a Kisqali Femara co-pack for this indication on September 17, 2024.
FDA
The agency granted accelerated approval for entrectinib in younger children with NTRK fusion-positive solid tumors and authorized a new dosage form.
FDA
The agency cleared the drug, sold as Augtyro, for patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
FDA
Opdivo is now approved for patients 12 and older with completely resected Stage IIB/C melanoma; a separate record lists a subcutaneous nivolumab-hyaluronidase approval with no details given.
FDA (3)
The agency updated labeling for Merck's temozolomide (Temodar) on September 14, 2023, as part of an effort to refresh information on older oncology drugs.
FDA
The agency cleared cabozantinib for patients 12 and older whose disease progressed after VEGFR-targeted therapy and who cannot receive or do not respond to radioactive iodine.
FDA
The March 16, 2023 approval covers patients age 1 and older with low-grade glioma who require systemic therapy.
FDA
One record covers osimertinib with chemotherapy for EGFR-mutated disease, while a separate record confirms approval for stage III disease following chemoradiation without specifying mutation status.
FDA (2)
Company says cash funds operations into 2030 through multiple Phase 3 readouts and potential launch of VDPHL01, with female pattern hair loss data due in 1H27.
SEC filing (2)
The agency cleared the kinase inhibitor, sold as Pimjetmi, for adults whose TGCT surgery could cause worse function or severe morbidity.
FDA
The company dosed its first breast cancer trial patient in July and reported about 72% growth in HEPZATO treatment volume for the third quarter.
FDA, SEC filing (2)
The approval, dated November 15, 2024, covers adult and pediatric patients age 1 and older with relapsed or refractory disease carrying a KMT2A translocation.
FDA
The approval, dated February 3, 2023, covers unresectable locally advanced or metastatic disease.
FDA
The agency cleared remestemcel-L-rknd for children 2 months and older with steroid-refractory acute graft versus host disease.
FDA
The agency cleared polatuzumab vedotin-piiq with R-CHP for adult patients with previously untreated diffuse large B-cell lymphoma and high-grade B-cell lymphoma.
FDA
TriSalus posted $12.9 million in third-quarter revenue and narrowed 2026 revenue guidance to $46 million to $48 million as new Medicare reimbursement rules take effect in 2027.
SEC filing
Atossa says it expects FDA clearance of its DMD and McCune-Albright Syndrome IND applications for (Z)-endoxifen in early 2027, with Phase 2 trials to follow.
SEC filing
A supply batch failed to meet release specifications, delaying the Phase 1b/2 readout, while cash fell to $82.9 million and now stretches into 2028.
SEC filing
The voucher is intended to support a future filing in BioNTech's late-stage oncology pipeline, pending customary closing conditions.
SEC filing
Five-year CARTITUDE-2 data and an FDA IND clearance for a new in vivo CAR-T candidate accompanied a leadership change and swing to profitability.
SEC filing
Xilio reported third-quarter 2026 results alongside pipeline updates, including dosing in the XTX501 lung cancer trial and two preclinical programs advancing toward 2027 IND filings.
SEC filing
Protalix said its Phase 2 RELEASE study of PRX-115 for uncontrolled gout continues to enroll patients, with top-line results expected in the second half of 2027.
SEC filing
Sionna Therapeutics said it will advance SION-451 plus SION-2222 into the AscenSION CF proof-of-concept trial, with cash expected to last into the second half of 2029.
SEC filing
Arbutus reported a $337.5 million cash position for the third quarter of 2026 and said the FDA cleared AB-101 for further U.S. development while it widened LNP patent litigation against Pfizer and BioNTech.
SEC filing
The company said it still expects to start Phase 3 trials in severe asthma and CRSwNP in the first quarter of 2027, backed by $207.4 million in cash as of September 30.
SEC filing
PMV Pharma said completed enrollment and updated Phase 2 data support an accelerated approval filing for ovarian cancer, backed by a $50 million offering.
SEC filing
BrainsWay reported third-quarter 2026 revenue of $18.1 million, cited new suicidal ideation and Alzheimer's-related data, and disclosed a post-quarter collaboration with a Southern California psychiatric network.
SEC filing
The company initiated two new oncology studies in October and November and said a first-line zipalertinib NDA submission is expected to complete in November.
SEC filing
Scholar Rock's third-quarter update details the September FDA approval and U.S. launch of ISEMBYLD, regulatory filings in Europe and Japan, and a definitive agreement to sell its priority review voucher to BioNTech US.
SEC filing
Topline data from the Phase 2/3 trial of COYA 302 in ALS are expected in early Q2 2027, with cash now seen lasting into the second half of that year.
SEC filing
MaxCyte announced a proposed acquisition of Akron BioProducts and third-quarter revenue of $10.2 million, with full-year guidance now at least $34.5 million.
SEC filing
Ovid said its Phase 2 focal epilepsy study of OV329 is expected to read out in the second half of 2027, with several other readouts set for early 2027 and cash extending into 2029.
SEC filing
The company said the dose cohort hit the highest splicing correction yet reported in a multiple-dose study, as its highest dose cohort finished enrolling and cash reached $104.8 million.
SEC filing
The company began its SOLARA pivotal trial of sutacimig and disclosed early Factor VII deficiency data, with cash runway guided into 2029.
SEC filing
Cohort 2 dosing wraps in the BEST1 program, the LCA5 Phase 3 trial is fully enrolled, and an RDH12 IND clearance adds a third clinical-stage gene therapy as cash runway extends into 2029.
SEC filing
The Baltimore-based biotechnology company reported one investor and a sale date of September 2, 2026, in a notice filed with the SEC.
SEC filing
Third quarter update details Phase 1b pulmonary hypertension trial plans, FDA alignment on a Phase 2b acute pancreatitis design, and $13.8 million in cash.
SEC filing
Tyra Biosciences posted initial ablative-study results in low-grade NMIBC and said a $400 million offering extends its cash runway through 2030.
SEC filing
The company says it is still positioned to begin dosing in its Phase 3 WM trial in early 2027 and to file for accelerated approval with the FDA in the first half of that year.
SEC filing
Olema said it remains on track to report top-line results from its pivotal Phase 3 OPERA-01 trial of palazestrant in the first quarter of 2027, while enrollment continues in a second pivotal trial and an early-stage.
SEC filing
Celairis will handle regulatory filings and commercialization of the retinitis pigmentosa gene therapy across the region while Ocugen retains manufacturing rights and collects royalties and profit share.
SEC filing