FDA's zanubrutinib record expands with CLL/SLL approval detail
A separate FDA notice shows zanubrutinib, sold as Brukinsa, was approved January 19, 2023 for chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA (2)
Latest
Today
Fate Therapeutics gives Q3 2026 update on lupus CAR T program and FT839 trial sites
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)
Insmed Q3 revenue tops $524 million; Brinsupri, Arikayce guidance raised, Japan launch underway
Insmed raised full-year guidance for both drugs after strong Q3 growth and advanced three initiated Phase 3 TPIP trials, with a fourth planned for 2027.
SEC filing (7)
Yesterday
FDA updates fludarabine phosphate labeling under Project Renewal
The agency approved revised labeling for Sandoz's fludarabine phosphate injection as part of an effort to refresh information on older cancer drugs.
FDA
Larimar completes rolling BLA for nomlabofusp in Friedreich's ataxia
The company seeks accelerated approval using skin frataxin as a surrogate endpoint, with FDA review and a possible launch targeted for 2027.
SEC filing
FDA accelerated approval for Enhertu in HER2-positive solid tumors, dated April 5, 2024
The FDA's own posting records accelerated approval for fam-trastuzumab deruxtecan-nxki for adults with unresectable or metastatic HER2-positive solid tumors.
FDA (2)
Artiva details wind-down cost estimates after scrapping AlloNK program
The company now pegs total charges from its workforce cut and trial shutdown at $27 million to $35 million, with most costs expected in Q4 2026.
SEC filing
HCRN withdraws phase 2 zanzalintinib trial in advanced urothelial carcinoma
The funder pulled support for the single-arm study before any participants enrolled, according to the ClinicalTrials.gov record last updated November 9, 2026.
ClinicalTrials.gov
FDA accelerated approval covers Padcev plus Keytruda in urothelial carcinoma
The agency's 2023 clearance applies to patients with locally advanced or metastatic urothelial carcinoma who cannot receive cisplatin-based chemotherapy.
FDA (10)
FDA grants accelerated approval to lifileucel for melanoma
The FDA approved lifileucel for unresectable or metastatic melanoma under its accelerated approval pathway.
FDA
FDA updates capecitabine tablet labeling under Project Renewal
The agency approved revised labeling for capecitabine tablets, adding new indications and dosing regimens.
FDA
FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer
The FDA's announcement confirms full approval for dostarlimab-gxly in mismatch repair deficient endometrial cancer, as of the posted record.
FDA (2)
FDA approves Sunharbo, first factor XIa inhibitor, for secondary stroke prevention
Bayer's asundexian, combined with antiplatelet therapy, cut ischemic stroke risk 26% versus placebo in a phase 3 trial of over 12,000 patients.
FDA press release
FDA clears zenocutuzumab-zbco under accelerated pathway for two tumor types
The agency's accelerated approval covers both non-small cell lung cancer and pancreatic adenocarcinoma, according to an FDA posting.
FDA
FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
The agency authorized Genmab's bispecific T-cell engager for adults with follicular lymphoma that has returned or stopped responding after prior treatment.
FDA
FDA grants traditional approval to tepotinib for MET exon 14 NSCLC
The agency approved the EMD Serono drug, marketed as Tepmetko, on February 15, 2024 for adults with metastatic non-small cell lung cancer carrying MET exon 14 skipping alterations.
FDA
FDA approved vorasidenib for IDH-mutant Grade 2 glioma in August 2024
The approval covers adult and pediatric patients 12 and older with Grade 2 astrocytoma or oligodendroglioma carrying a susceptible IDH1 or IDH2 mutation.
FDA
Surrozen doses first DUET patient, expands Phase 2a to 150 patients in DME study
Surrozen reported the first patient dosed in its SZN-8141 Phase 1b/2a trial and a planned Phase 2a enrollment increase, alongside added capital extending cash runway into 2029.
SEC filing
Amgen registers Phase 3 MARITIME-PEN trial testing home autoinjector for maridebart cafraglutide
Zai Lab discloses $249.9 million private securities offering in SEC Form D
The filing shows all shares already sold to 25 investors, with Leerink Partners serving as placement agent.
SEC filing
Zymeworks raises 2026 guidance after $250M Ziihera milestone, posts Roche deal for ZW209
Zymeworks reported third-quarter 2026 results, raised full-year revenue and EBITDA guidance, and detailed a new Roche collaboration on ZW209 pending antitrust clearance.
SEC filing
AFT-19 prostate cancer trial comparing apalutamide combinations posts results, marked completed
Sanofi registers Phase 2b trial of duvakitug in hidradenitis suppurativa, recruiting
Immuneering appoints Grant C. Bogle to board as Class III Director
The Cambridge biotech added Bogle to its board effective November 9, 2026, with no committee assignment yet disclosed.
SEC filing
Trevi reports Q3 2026 results, three chronic cough trials now recruiting
Trevi Therapeutics said its Phase 3 OCEAN-2 trial opened in the third quarter and all three active trials are enrolling, with cash into 2030.
SEC filing
Boehringer posts BI 1291583 bioavailability results; registers three new trials
AbCellera reports Q3 2026 results, highlights ABCL635 Phase 2 and $200M raise
Positive Phase 2 data for menopause drug ABCL635 and a $200 million share offering anchor the quarter, alongside Phase 1 results for ABCL575 that will not advance past that stage.
SEC filing
Novartis updates pediatric asciminib CML trial; opens new schizophrenia drug study
iSpecimen closes $400,000 Series D preferred stock private placement
The Woburn, Massachusetts-based specimen marketplace sold 500 shares of newly created Series D Convertible Preferred Stock to accredited investors, with E.F. Hutton as placement agent.
SEC filing
Maze Therapeutics completes HORIZON enrollment, reports Q3 2026 results
Maze finished enrolling its Phase 2 HORIZON trial of MZE829 with more than 50 patients and said full data are expected in early 2027, while cash stood at $477 million.
SEC filing
Pfizer registers Phase 3 marstacimab hemophilia trial and elranatamab myeloma comparison study
GSK posts results for two trials: DREAMM 9 myeloma combo and HSV immunotherapy study
Merck registers tulisokibart trials in sarcoidosis, uveitis; backs prostate cancer ADC study
Jazz Pharmaceuticals' Phase I ONC206 trial in CNS neoplasms updated, remains active not recruiting
Rani Therapeutics gets FDA Emerging Technology Program acceptance, updates RT-114 enrollment
Rani reported third-quarter 2026 results, citing the FDA program acceptance and continued RT-114 expansion enrollment alongside a cash runway statement through at least the end of 2027.
SEC filing
SIGA gets $15M Canadian defense contract for oral TPOXX, discloses CSO retirement
SIGA Technologies reported financial results for the third quarter and first nine months of 2026 on November 9, 2026, alongside operational updates on its smallpox antiviral TPOXX.
SEC filing
ImageneBio reports Q3 2026 results, reaffirms olevaprubart trial timelines
The company said its Phase 2b atopic dermatitis trial remains on track for topline data in Q4 2027 and a new alopecia areata study is set to start by year end 2026.
SEC filing
Definium reports positive Phase 3 results for DT120 ODT in GAD, FDA breakthrough status in MDD
The company posted two positive Phase 3 anxiety studies, an MDD breakthrough designation, and roughly $1.05 billion in cash as of September 30, 2026.
SEC filing
Atea reports Phase 3 HCV win, HEV progress, and new Hercules credit line
Atea's C-BEYOND trial hit its endpoints for BEM/RZR in hepatitis C, while a new $200 million Hercules Capital facility backs a planned US launch.
SEC filing
CervoMed reports Q3 2026 results and neflamapimod pipeline progress across four programs
The company detailed data, regulatory steps, and a new dosing regimen across dementia with Lewy bodies, FTD, ALS, and stroke recovery programs, while cash stood at $19.6 million.
SEC filing
Lilly posts Phase 2b retatrutide renal results; registers tersolisib kidney PK study
Sanofi's Japan teplizumab trial for Stage 2 Type 1 Diabetes is active, not recruiting
Attovia reports Phase 1b itch drug topline data, plans Phase 2 starts in 1H 2027
ATTO-1310 hit week-12 itch and skin endpoints in chronic pruritus and atopic dermatitis patients, with two Phase 2 trials targeted to begin in the first half of 2027.
SEC filing
RenJi Hospital registers long-term follow-up study for Gracell's GC012F in multiple myeloma
UT Health San Antonio registers Phase 1/2 trial of Corcept's relacorilant in T2D with cortisol exces
Beth Israel registers Phase II lifileucel TIL trial for kidney cancer with Iovance
AbbVie registers Phase 1 PK study of trosunilimab given IV and SC in healthy adults
Annexon posts Q3 2026 results, flags tanruprubart BLA and ARCHER II readout timing
The company said its U.S. BLA for tanruprubart is expected this quarter and the ARCHER II Month 15 primary endpoint assessment for vonaprument is on track for the fourth quarter of 2026.
SEC filing
Harrow posts record Q3 revenue, cuts 2026 Adjusted EBITDA outlook
Harrow reported record Q3 2026 revenue, mixed Phase 4 IHEEZO data, and a lowered full-year Adjusted EBITDA target tied to added spending on its G-MELT NDA and TYRVAYA integration.
SEC filing
Lisata adjourns vote on preferred stock conversion, reconvenes November 30
Stockholders approved a reverse stock split and two equity plans at the 2026 annual meeting but did not vote on converting Series C preferred stock.
SEC filing