FDA approves capivasertib combo for PTEN-deficient prostate cancer
The agency cleared capivasertib with abiraterone and prednisone for PTEN-deficient, androgen pathway modulation-naïve or -sensitive metastatic prostate cancer.
FDA (6)
Latest
Friday, November 6
FDA approves ivosidenib for myelodysplastic syndromes
The agency's announcement confirms the approval but does not provide additional detail on dosing, trial data, or indication specifics in the text provided.
FDA
The company: FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with
A record notice: the source is linked, and no summary was written because none passed the fact check.
FDA
FDA approves daraxonrasib as Elicio preps Phase 1 trial combining it with camupepimut
Revolution Medicines' RAS inhibitor gains approval in metastatic pancreatic cancer as Elicio targets a fourth-quarter combination study start and reports Q3 results.
FDA, SEC filing (3)
Satellos swaps primary endpoint in pediatric DMD trial after FDA feedback
Satellos Bioscience will now measure MRI-based muscle fat fraction, rather than dynamometry, as the main efficacy goal of its Phase 2 BASECAMP study.
SEC filing
Perspective reports VMT01 melanoma data and NANETS NET updates, Phase 3 targeted for 2027
New SITC 2026 data show a 75% disease control rate for VMT01 monotherapy in melanoma, as the company advances VMT-α-NET toward a 2027 Phase 3 study.
SEC filing (2)
FDA approved eflornithine for high-risk neuroblastoma in December 2023
The agency cleared the drug, marketed as IWILFIN by USWM, LLC, for patients who had responded at least partially to prior multiagent, multimodality therapy.
FDA
BioCardia finishes PMDA consultation process for CardiAMP in Japan
The company said the milestone moves its heart failure cell therapy closer to a Japanese marketing approval filing, with first patient treatments targeted for 2028.
SEC filing
FDA approves durvalumab plus BCG for high-risk non-muscle invasive bladder cancer
The agency's May 28, 2026 approval covers adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer.
FDA (2)
Enliven sticks to year-end ENABLE-2 start after FDA alignment on CML trial design
Enliven Therapeutics said it remains on track to begin the Phase 3 ENABLE-2 trial of relcobatinib before year-end 2026, with $884.4 million in cash to fund operations into 2030.
FDA, SEC filing (2)
FDA approves fruquintinib for refractory metastatic colorectal cancer
Takeda's Fruzaqla cleared for adults with mCRC after specific prior chemotherapy and anti-VEGF treatment, FDA says
FDA (2)
FDA approved axatilimab-csfr for chronic graft-versus-host disease in August 2024
Incyte's Niktimvo cleared for patients after at least two prior lines of systemic therapy failed.
FDA
Acrivon acquires JAK1 inhibitor ACR-525 from Aqilion, enters immunology
Acrivon Therapeutics paid cash for a Phase 2-ready oral JAK1 inhibitor and a preclinical PKCθ program, establishing immunology and inflammation as a new pillar alongside oncology.
SEC filing
Hengrui and Braveheart report 52-week data on HRS/BHB-1893 in obstructive HCM
At AHA Scientific Sessions 2026, the companies said open-label extension data showed durable LVOT gradient reductions and exercise gains, with most patients remaining on the starting dose.
SEC filing
FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
Amgen's Imdelltra gains traditional FDA approval for adults with ES-SCLC that progressed after platinum-based chemotherapy.
FDA
FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated breast cancer
The agency's approval covers advanced or metastatic breast cancer marked by ER-positive, HER2-negative status and an ESR1 mutation.
FDA
FDA approves ensartinib for ALK-positive locally advanced or metastatic NSCLC
The approval covers adult patients who have not previously received an ALK-inhibitor.
FDA
FDA grants accelerated approval to zongertinib for expanded lung cancer indication
The agency cleared the kinase inhibitor for adults with unresectable or metastatic non-squamous non-small cell lung cancer.
FDA
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic TNBC
The FDA has approved the antibody-drug conjugate for patients with unresectable or metastatic triple-negative breast cancer.
FDA
FDA approves Besponsa for pediatric ALL patients
The agency cleared inotuzumab ozogamicin for children 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia on March 6, 2024.
FDA
FDA approved erdafitinib for FGFR3-altered metastatic urothelial carcinoma in 2024
The agency cleared Balversa for patients with locally advanced or metastatic urothelial carcinoma whose disease had progressed after prior therapy.
FDA
FDA approves cosibelimab-ipdl for advanced skin cancer
The agency cleared the PD-L1 blocking antibody for metastatic or locally advanced cutaneous squamous cell carcinoma on December 13, 2024.
FDA
Rallybio and Avenzo postpone merger closing past November 6, 2026 target
Listing approvals remain outstanding, and Rallybio says a related cash distribution's payment and ex-dividend dates may also be delayed.
SEC filing
FDA approves Janssen's gemcitabine system for bladder cancer
The agency cleared Inlexzo for a specific group of bladder cancer patients who did not respond to standard BCG therapy.
FDA
FDA approves blinatumomab for consolidation in Ph-negative B-cell precursor ALL
The agency's June 14, 2024 approval covers Amgen's Blincyto for patients as young as one month with CD19-positive, Philadelphia chromosome-negative disease.
FDA
FDA approved nirogacestat for desmoid tumors in November 2023
The agency cleared OGSIVEO as the first approved treatment for adults with progressing desmoid tumors needing systemic therapy.
FDA
FDA grants accelerated approval to belantamab mafodotin-blmf for multiple myeloma
The agency's approval announcement names the drug and indication but does not detail trial data, dosing, or label specifics in the posted record.
FDA (3)
60 Degrees Pharmaceuticals strikes warrant inducement deal with existing holders
The company agreed to reprice existing warrants to $0.90 and issue new warrants for 200% more shares to raise roughly $526,000 before fees.
SEC filing
Vogenx initiates Phase 2b EMERGE trial of mizagliflozin for post-bariatric hypoglycemia
The company reported third-quarter 2026 results, with the trial underway and $82.1 million in cash after its August IPO.
SEC filing
Entera Bio advances EB613 toward Phase 3 osteoporosis trial, targets late 2026 site activation
The company reported third-quarter 2026 results alongside plans for its first Phase 3 trial site and new executive and board hires ahead of pivotal testing of its oral osteoporosis tablet.
SEC filing
Apollomics terminates LaunXP license deal for vebreltinib amid going concern doubt
The oncology company ended its Asia licensing pact with LaunXP after a missed payment, logged a $2.3 million impairment, and warned it may not have enough cash to operate for 12 months.
SEC filing
TuHURA Biosciences draws $1.5 million more on Parkview credit facility
The company disclosed a November 2, 2026 draw under its existing revolving loan with Parkview Holdings One LLC, earmarked for general corporate purposes.
SEC filing
Elanco raises 2026 outlook as Zenrelia, Credelio Quattro drive growth, hits leverage target early
Elanco reported third quarter revenue of $1.265 billion, raised full year guidance, and said it reached its 2.9x net leverage milestone ahead of schedule.
SEC filing
aTyr Pharma files amended at-the-market offering for up to $79.99 million
The prospectus supplement updates aTyr's Jefferies sales agreement while detailing EFZO-FIT trial results and a planned new Phase 3 study for pulmonary sarcoidosis.
SEC filing
CG Oncology sees PIVOT-006 topline data in November, BLA completion in Q4
The company said cash and marketable securities of $984.5 million as of September 30, 2026 should fund operations through 2029.
SEC filing
Passage Bio stockholders approve Remix Therapeutics merger proposals at special meeting
Shareholders voted on November 5, 2026 to approve the stock issuance, reverse split, and charter changes needed to complete the merger with Remix Therapeutics.
SEC filing
eXoZymes files S-1 for offering of common stock and purchase warrants
Nasdaq-listed eXoZymes filed a registration statement on November 6, 2026 for an offering of shares and purchase warrants to fund its NCT supplement and pipeline work.
SEC filing
Curis gets Nasdaq delisting notice over sustained sub-$1 share price
Curis said it plans to seek a new hearing to stay the delisting action after Nasdaq staff determined the stock failed the $1.00 minimum bid price rule for 30 straight business days.
SEC filing
Aligos reports Q3 2026 results, B-SUPREME trial on track for late Q3 2027 data
Enrollment is complete in the Phase 2 hepatitis B study of pevifoscorvir sodium, and Aligos says its cash runway extends into early 2027.
SEC filing
Silo Pharma closes private placement raising about $815,000
The company sold common stock and pre-funded warrants to accredited investors on November 5, 2026, with the deal closing the next day.
SEC filing
Sanofi's Phase 3 vYF yellow fever vaccine trial in children active, not recruiting
Zenas files new $200M stock offering as obexelimab BLA review continues
Zenas ended its prior at-the-market stock sale and filed a new $200 million offering under the same sales agreement, while reporting Q3 results and pipeline progress toward a May 2027 PDUFA date.
SEC filing (2)
Quoin reports positive interim QRX003 data, PSS designations, and Q3 2026 results
The company said its Netherton Syndrome study hit statistical significance on primary and key secondary endpoints as it advanced QRX003 into Peeling Skin Syndrome and closed a private placement of up to $50 million.
SEC filing
bioAffinity reports Q3 2026 CyPath Lung growth, raises $8.0 million year to date
Unit sales doubled and testing revenue rose 79% through the first nine months of 2026, while the company advanced its lung cancer trial and new asthma/COPD and skin cancer research.
SEC filing
Minerva reports Q3 2026 results, confirms roluperidone Phase 3 timelines
Minerva says its confirmatory C19 trial of roluperidone remains on track, with Phase A data due in the second half of 2027 and Phase B data in the second half of 2028.
SEC filing
Protara reports Q3 2026 results, updates timelines for TARA-002 and IV Choline Chloride
The company said it expects to finish enrolling a key NMIBC cohort by year-end and pushed back its lymphatic malformation enrollment completion to early 2027, with cash seen lasting into 2028.
SEC filing
BioVie prices $4.74 million offering, closes November 5
BioVie sold shares and pre-funded warrants in a registered direct offering alongside a private placement of common warrants, with proceeds earmarked for working capital.
SEC filing
Valneva to report nine-month 2026 financial results on November 24, 2026
The specialty vaccine company said it will hold a live webcast to discuss results and give a business update.
SEC filing