Ahead of its October 24 goal date, on September 11, the FDA approved Joenja (leniolisib) - paediatric APDS (Pharming Group N.V., PHAR) in activated PI3K-delta syndrome (APDS) in children (resubmission covering patients weighing 27 kg or more).
On October 2, the FDA approved Jaypirca (pirtobrutinib) - previously untreated CLL/SLL (ELI LILLY & Co, LLY) in adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.
On October 6, the FDA approved Rhapsido (remibrutinib) - symptomatic dermographism (Novartis Ag, NVS) in adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines.
On October 7, the FDA approved Tukysa (tucatinib) + trastuzumab + pertuzumab (PFE).
Ahead of its October 9 goal date, on October 8, the FDA approved Tecentriq (atezolizumab) - adjuvant Stage III dMMR colon cancer (Roche Holding AG, RHHBY) in in combination with a fluoropyrimidine and oxaliplatin, adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer.
On October 8, the FDA approved Weltruza (olanzapine) extended-release (TEVA).
On October 9, the FDA approved Repatha (evolocumab) - cardiovascular risk (AMGN).
Ahead of its January 6 goal date, on October 14, the FDA approved ANKTIVA (N-803) + BCG - papillary-only BCG-unresponsive NMIBC (ImmunityBio, Inc., IBRX) in with BCG, adults with BCG-unresponsive non-muscle invasive bladder cancer; now includes high-grade papillary-only tumors as well as CIS with or without papillary tumors.
On October 15, the FDA approved Enspryng (satralizumab) - thyroid eye disease (Roche Holding AG, RHHBY) in adults with thyroid eye disease (TED).
Ahead of its October 17 goal date, on October 16, the FDA approved Phentolamine ophthalmic solution 0.75% (Opus Genetics, Inc., IRD) in presbyopia in adults (sNDA; RYZUMVI was already approved for pharmacologically induced mydriasis).
Ahead of its October 17 goal date, on October 16, the FDA approved MR-141 (phentolamine ophthalmic solution 0.75%) (Viatris Inc., VTRS) in presbyopia in adults (sNDA; RYZUMVI was already approved for pharmacologically induced mydriasis).
On October 19, within the window the sponsor had given (February 2027; no goal day was published), the FDA approved Jemperli (dostarlimab-gxly) - locally advanced rectal cancer (GSK plc, GSK) in adults with Stage II/III locally advanced rectal cancer that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test (accelerated approval).
Ahead of its October 26 goal date, on October 20, the FDA approved Hibsago (bepirovirsen) - chronic hepatitis B (GSK plc, GSK) in chronic hepatitis B virus infection, in combination with nucleos(t)ide analogue therapy, in adults without cirrhosis on that therapy for at least 6 months with suppressed HBV DNA and HBsAg of 3,000 IU/mL or less (FDA-authorized test).
October 30: the FDA is due to decide on INO-3107 DNA immunotherapy (Inovio Pharmaceuticals, INO) in recurrent respiratory papillomatosis (RRP) BLA. That is the goal date; the agency can act earlier or extend it.
Ifinatamab deruxtecan (I-DXd) (MRK): the application was withdrawn by the sponsor on September 25, 2026, before its October 10, 2026 goal date. No FDA decision was issued (sponsor release).
November 1: the FDA is due to decide on Mitapivat (PYRUKYND) - (RISE UP) (Agios Pharmaceuticals, AGIO) in sickle cell disease (sNDA). That is the goal date; the agency can act earlier or extend it.
November 14: the FDA is due to decide on IGALMI (dexmedetomidine sublingual film) - (SERENITY At-Home) (BioXcel Therapeutics, BTAI) in at-home agitation in bipolar disorder or schizophrenia (sNDA). That is the goal date; the agency can act earlier or extend it.
November 14: the FDA is due to decide on Aficamten - (MAPLE-HCM) (Cytokinetics Inc, CYTK) in non-obstructive hypertrophic cardiomyopathy. That is the goal date; the agency can act earlier or extend it.
November 14: the FDA is due to decide on Ivonescimab (Summit Therapeutics Inc., SMMT). That is the goal date; the agency can act earlier or extend it.
November 22: the FDA is due to decide on Deramiocel (CAP-1002) - (HOPE-3) (Capricor Therapeutics Inc., CAPR) in duchenne muscular dystrophy; refined proposed indication focused on upper limb function. That is the goal date; the agency can act earlier or extend it.
November 22: the FDA is due to decide on MOLBREEVI (molgramostim inhalation) - (IMPALA-2) (Savara, SVRA) in autoimmune pulmonary alveolar proteinosis (aPAP) BLA. That is the goal date; the agency can act earlier or extend it.
November 27: the FDA is due to decide on BBP-418 (ribitol) - (FORTIFY) (BridgeBio Pharma, Inc., BBIO) in limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). That is the goal date; the agency can act earlier or extend it.
November 30: the FDA is due to decide on Bezuclastinib + sunitinib - (PEAK) (Cogent Biosciences, COGT) in gastrointestinal stromal tumors (GIST), 2L+. That is the goal date; the agency can act earlier or extend it.
November 30: the FDA is due to decide on Giredestrant (lidERA) (Roche Holding AG, RHHBY) in adjuvant early breast cancer (ER+/HER2-). That is the goal date; the agency can act earlier or extend it.
November 30: the FDA is due to decide on Povetacicept (ALPN-303) (Vertex, VRTX) in igA nephropathy. That is the goal date; the agency can act earlier or extend it.
Dated by the FDA's own record (the approval letter, Drugs@FDA or the FDA's approval notice), not the company's announcement. Every letter: FDA approval letters.
October 20, 2026: the FDA approved Hibsago (bepirovirsen) (GSK, FDA press announcement, October 20, 2026 (letter not yet on Drugs@FDA)).
October 19, 2026: the FDA approved Jemperli (dostarlimab-gxly) (GSK, FDA accelerated approval notification (sBLA, BLA 761174; letter not yet on Drugs@FDA)).
October 16, 2026: the FDA approved Phentolamine ophthalmic solution 0.75% (IRD/VTRS, NDA 217064 S-005).
October 15, 2026: the FDA approved Enspryng (satralizumab) (RHHBY, BLA 761149 S-008).
October 14, 2026: the FDA approved ANKTIVA (N-803) + BCG (IBRX, FDA approval notification (sBLA, BLA 761336; letter not yet on Drugs@FDA)).
October 9, 2026: the FDA approved Repatha (evolocumab) - cardiovascular risk reduction label expansion (VESALIUS-CV) (AMGN, BLA 125522 SUPPL-47).
October 8, 2026: the FDA approved Tecentriq (atezolizumab) (RHHBY, FDA approval notification (sBLA; letter not yet on Drugs@FDA)); Weltruza (olanzapine) extended-release injectable suspension (TEV-749) (TEVA, NDA 219007 ORIG-1).
October 7, 2026: the FDA approved Tukysa (tucatinib) + trastuzumab + pertuzumab - HER2+ metastatic breast cancer maintenance (HER2CLIMB-05) (PFE, NDA 213411 SUPPL-10).
October 6, 2026: the FDA approved Rhapsido (remibrutinib) (NVS, NDA 218436 S-001 (openFDA AP 2026-10-06; letter listed, not yet posted)).
October 2, 2026: the FDA approved Jaypirca (pirtobrutinib) (LLY, FDA approval notification, NDA 216059).
September 30, 2026: the FDA approved Camzyos (mavacamten) - pediatric oHCM (SCOUT-HCM) (BMY, NDA 214998 SUPPL-13).
September 25, 2026: the FDA approved Gazyva (obinutuzumab) (RHHBY, BLA 125486 SUPPL-43); Atebrioz (zilurgisertib) (INCY/MIRM, NDA 221198 ORIG-1); JUVMO (tavapadon) (ABBV, NDA 220415 ORIG-1); Olumiant (baricitinib) (LLY, NDA 207924 SUPPL-9); Degevma (denosumab-adet), biosimilar to and interchangeable with Xgeva (TEVA, BLA 761481 ORIG-1).
September 24, 2026: the FDA approved Welireg (belzutifan) plus Lenvima (lenvatinib) (MRK, NDA 215383 SUPPL-13).
September 23, 2026: the FDA approved Onswik (insulin efsitora alfa-gobe) (LLY, BLA 761408 ORIG-1).
September 21, 2026: the FDA approved WINREVAIR (sotatercept-csrk) (MRK, BLA 761363 S-017).
September 18, 2026: the FDA approved Inluriyo (imlunestrant) + Verzenio (abemaciclib) (LLY, NDA 218881 S-001).
September 17, 2026: the FDA approved FAYUVI (rebisufligene etisparvovec-hopf; UX111 / ABO-102) (RARE, CBER approval letter (FAYUVI)).
September 16, 2026: the FDA approved KERENDIA (finerenone), T1D-CKD (BAYRY, NDA 215341 S-011); IBTROZI (taletrectinib) sNDA (NUVB, NDA 219713 S-004).
September 11, 2026: the FDA approved Pixclara (floretyrosine F 18; TLX101-Px) (TLX, NDA 218592 ORIG-1); ISEMBYLD (apitegromab-mstn) (SRRK, BLA 761463 ORIG-1); Joenja (leniolisib) (PHAR, NDA 217759 S-006).
September 9, 2026: the FDA approved Ameluz (aminolevulinic acid hydrochloride) with RhodoLED red light - sBCC (BFRI, NDA 208081 S-040); HYRNUO (sevabertinib) - HER2-mutant NSCLC (BAYRY, NDA 219972 S-001).
Dates and outcomes only, each linked to its record; see this week's decisions, the full calendar and what a PDUFA date is. Not a prediction about any pending application, and not investment advice.