PDUFA target action dates that companies disclosed in SEC filings, each checked against the quoted sentence. FDA advisory committee meetings from FDA's calendar, each checked against FDA's notice in the Federal Register. CHMP meetings from EMA's published schedule with the latest meeting's outcomes from EMA's meeting highlights, and European Commission decisions awaited after a positive opinion, from EMA's medicine data and the EU Union Register. Expected dates are estimates: 55 to 67 days after the opinion, the 10th to 90th percentile of the 187 human medicines authorised in the last two years (median 60 days). A decision is shown only when the Union Register lists it.
40 PDUFA dates ahead · Next FDA advisory committee Oct 30, 2026 · Next CHMP meeting Nov 9 – 12, 2026 · 18 expected · 1 past the window · 7 decided · 5 negative opinions open · EMA data as of Oct 18, 2026 · checked Oct 18, 2026.
FDA does not publish PDUFA dates; companies disclose them in SEC filings. Each date below is quoted from the company's filing and was checked on Oct 18, 2026. FDA can act before the date, and a date moves when FDA extends the review.
Recurrent respiratory papillomatosis
Operational Highlights INO-3107 – Recurrent Respiratory Papillomatosis (RRP) The FDA’s review of the BLA for INO-3107 continues to advance under the Agency’s accelerated approval program toward a PDUFA target action date of October 30, 2026.
SEC filing of Aug 12, 2026
Sickle cell disease
The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1, 2026.
SEC filing of Jul 30, 2026
At-home acute treatment of agitation in bipolar disorders or schizophrenia
In the quarter ended on March 31, the FDA accepted the Company’s supplemental New Drug Application (sNDA) for IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia and assigned a PDUFA target action date of November 14, 2026.
SEC filing of May 15, 2026
Obstructive hypertrophic cardiomyopathy (MAPLE-HCM)
The Supplemental New Drug Application for MAPLE-HCM was accepted for filing by the U.S. Food and Drug Administration (FDA) with a PDUFA date of November 14, 2026.
SEC filing of May 5, 2026
EGFR-mutated non-small cell lung cancer after TKI therapy
Summit’s Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) is based on the results from the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
SEC filing of Sep 15, 2026
Duchenne muscular dystrophy
… has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD), from August 22, 2026 to November 22, 2026.
SEC filing of Aug 24, 2026 Earlier target date: Aug 22, 2026.
Limb-girdle muscular dystrophy type 2I/R9
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026, and BridgeBio is poised to launch BBP-418 upon approval.
SEC filing of May 27, 2026
ALK-positive non-small cell lung cancer after a TKI
In May 2026, Nuvalent announced the FDA accepted its NDA for neladalkib for filing and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) date of November 27, 2026.
SEC filing of Aug 5, 2026
Reported in Royalty Pharma's 8-K, citing Nuvalent's announcement; GSK gives "PDUFA H2 2026".
Prevention of surgical site infections
The U.S. Food and Drug Administration (“FDA”) has accepted PolyPid’s NDA for D-PLEX₁₀₀ and granted Priority Review, with a Prescription Drug User Fee Act (“PDUFA”) goal date of November 28, 2026.
SEC filing of Oct 1, 2026
Gastrointestinal stromal tumor
Anticipated Upcoming Milestones Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026 …
SEC filing of Aug 10, 2026
IgA nephropathy
The U.S. FDA accepted the BLA submission for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026.
SEC filing of Aug 3, 2026
Generalized pustular psoriasis
Other Updates The Biologics License Application (BLA) for Quimilza TM in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.
SEC filing of Aug 5, 2026
Cushing's syndrome
Hypercortisolism (Cushing’s Syndrome) Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026 …
SEC filing of Jul 29, 2026
Hypertension
Recent Highlights and Upcoming Milestones Lorundrostat New Drug Application (NDA) — The U.S. Food and Drug Administration (FDA) continues its review of the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs, with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.
SEC filing of Aug 11, 2026
Relapsed or refractory multiple myeloma, fourth line or later
Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026.
SEC filing of May 7, 2026
SCN2A and SCN8A developmental and epileptic encephalopathies
On June 29, 2026, Praxis Precision Medicines, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) notified the Company that it has extended by three months the review period for its New Drug Application (“NDA”) for relutrigine for the treatment of SCN2A and SCN8A developmental and epileptic encephalopathies (“DEEs”), setting an updated PDUFA target action date from September 27, 2026 to December 27, 2026 …
SEC filing of Jun 29, 2026 Earlier target date: Sep 27, 2026.
Moderate-to-severe acute pain
The FDA has assigned a PDUFA goal date of December 27, 2026.
SEC filing of Aug 6, 2026
Non-advanced systemic mastocytosis
Announced the FDA accepted its NDA for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026 …
SEC filing of May 5, 2026
Duchenne muscular dystrophy (exon 51)
Key milestones for z-rostudirsen Dyne’s BLA was accepted for review by the FDA in July 2026, with Priority Review granted (Prescription Drug User Fee Act (PDUFA) target action date set for January 21, 2027).
SEC filing of Jul 29, 2026
Essential tremor
NDA review is progressing as expected, with a PDUFA date of January 29, 2027.
SEC filing of Aug 6, 2026
APDS, children aged 4 and older weighing 13 to 27 kg
The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2027.
SEC filing of Sep 25, 2026
Achondroplasia in children
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027, and BridgeBio is prepared to launch oral infigratinib upon approval.
SEC filing of Oct 13, 2026
Stargardt disease type 1
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of February 12, 2027.
SEC filing of Aug 11, 2026
Atopic dermatitis in infants aged 3 to 24 months
The FDA accepted an sNDA for ZORYVE cream 0.05% to expand the indication for the treatment of mild to moderate atopic dermatitis in infants aged 3 to 24 months with a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027.
SEC filing of Aug 5, 2026
EGFR exon 20 insertion non-small cell lung cancer
An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.
SEC filing of Oct 2, 2026
Obstructive sleep apnea
The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of February 28, 2027.
SEC filing of Sep 8, 2026
Achondroplasia in children
In July, BioMarin announced that the FDA accepted its sNDA for full approval of VOXZOGO in children with achondroplasia, with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.
SEC filing of Aug 6, 2026
Previously treated metastatic colorectal cancer
The updated Prescription Drug User Fee Act action date is March 3, 2027.
SEC filing of Sep 11, 2026 Earlier target date: Dec 3, 2026.
Hereditary angioedema
… has accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review with a PDUFA target action date of March 10, 2027.
SEC filing of Sep 8, 2026
Myelofibrosis-associated anemia with concomitant JAK inhibitor therapy
The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027.
SEC filing of Jul 30, 2026
Type I allergic reactions, including anaphylaxis
… has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027, in keeping with the FDA’s classification of the resubmission as a Class 2 response.
SEC filing of Oct 15, 2026
Seizure clusters, ages 6 to 11
The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.
SEC filing of Oct 14, 2026
Narcolepsy
… Pitolisant GR NDA Accepted in July; Target PDUFA Date April 1, 2027 …
SEC filing of Aug 4, 2026
Conventional chondrosarcoma
In June 2026, the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s biologics license application (BLA) for the potential approval of ozekibart in conventional chondrosarcoma and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027.
SEC filing of Aug 13, 2026
On-demand treatment of hereditary angioedema attacks
In July 2026, the U.S. Food and Drug Administration (FDA) accepted to review the Company’s New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks, with the Prescription Drug User Fee Act (PDUFA) action date set for April 23, 2027.
SEC filing of Aug 12, 2026
Desmoid tumors
Pipeline Highlights Varegacestat: In July 2026, the U.S. FDA accepted Immunome’s NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027.
SEC filing of Aug 11, 2026
Cataplexy in narcolepsy
Narcolepsy: Axsome’s NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy was accepted by the FDA and assigned a PDUFA target action date of May 1, 2027.
SEC filing of Aug 10, 2026
Autosomal dominant hypocalcemia type 1
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 8, 2027, and BridgeBio is prepared to launch encaleret upon approval, representing a potential blockbuster opportunity for the Company.
SEC filing of Jul 22, 2026
BridgeBio's 8-K of 2026-08-31 gives May 7, 2027; its announcement of the acceptance and its 8-K of 2026-08-10 give May 8.
Relapsed or refractory multiple myeloma
mezigdomide July 13 The FDA accepted a New Drug Application for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM), granting a PDUFA date of May 13, 2027.
SEC filing of Jul 30, 2026
IgG4-related disease
Corporate highlights Obexelimab, a CD19 and FcγRIIb inhibitor of B cell function · In August, the U.S. Food and Drug Administration (FDA) accepted the Company’s Biologics License Application (BLA) for obexelimab for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD): The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027.
SEC filing of Aug 13, 2026
Presbyopia
The FDA has assigned a PDUFA goal date of October 17, 2026.
SEC filing of Feb 26, 2026
No FDA action found in the company's filings or Drugs@FDA as of the review on Oct 18, 2026.
BCG-unresponsive non-muscle invasive bladder cancer, papillary disease
… The FDA accepted for review the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with papillary disease without CIS and assigned a PDUFA target action date of January 6, 2027 …
SEC filing of Aug 4, 2026
… has expanded the approved indication for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive NMIBC with papillary-only tumors.
Company filing
Fibrodysplasia ossificans progressiva
The FDA has accepted the NDA for zilurgisertib in FOP under Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.
SEC filing of Aug 5, 2026
Approval of Atebrioz On September 25, 2026, Mirum Pharmaceuticals, Inc. (the “Company”) and Incyte Corporation (“Incyte”) announced that the U.S. Food and Drug Administration (“FDA”) approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification (“HO”) in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (“FOP”).
Company filing
Pulmonary arterial hypertension
In February 2026, FDA accepted a new sBLA for WINREVAIR seeking approval to update the U.S. product label based on Phase 3 HYPERION trial. FDA set PDUFA date of September 21, 2026.
SEC filing of Feb 3, 2026
Drugs@FDA lists supplements to BLA 761363 approved on 2026-09-21; Merck has filed no 8-K on it. Drugs@FDA
Mucopolysaccharidosis type IIIA (Sanfilippo syndrome type A)
The FDA set a Prescription Drug User Fee Act (PDUFA) action date of September 19, 2026.
SEC filing of Apr 2, 2026
On September 17, 2026, Ultragenyx Pharmaceutical Inc. (“Ultragenyx” or the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) granted standard full approval of FAYUVI™ (rebisufligene etisparvovec-hopf), also known as UX111, for the treatment of pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome Type A).
Company filing
Superficial basal cell carcinoma
Recent Operational Highlights Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz ® PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026.
SEC filing of May 14, 2026
On September 14, 2026, Biofrontera Inc. (the “Company”) issued a press release announcing that it has received notification from the U.S. Food and Drug Administration (the “FDA”) that the FDA had approved the Company’s supplemental New Drug Application for Ameluz ® (aminolevulinic acid …
Company filing
Spinal muscular atrophy
SMA Program Apitegromab Biologics License Application (BLA) on track for potential FDA approval by September 30, 2026 Prescription Drug User Fee Act (PDUFA) date.
SEC filing of Aug 6, 2026
… Scholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA) September 11, 2026 · ISEMBYLD is approved for use in all adults and children ≥2 years of age with SMA who are currently …
Company filing
Alexander disease
Zilganersen is currently under Priority Review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date of September 22, 2026.
SEC filing of Apr 21, 2026
On September 3, 2026, Ionis announced that the U.S. FDA has approved ZANVASTRO™ (zilganersen) for the treatment of AxD in pediatric and adult patients.
Company filing
ROS1-positive non-small cell lung cancer after a ROS1 TKI
The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026.
SEC filing of Jan 14, 2026
Issued: 22 July 2026, London UK Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer Approval based on ARROS-1 phase I/II trial demonstrating meaningful and durable responses in patients with locally advanced or metastatic disease [1] …
Company filing
Federal Register notice of Sep 25, 2026 gives the same date.
Federal Register notice of Sep 16, 2026 gives the same date.
Federal Register notice of Sep 9, 2026 gives the same date. Materials, and the minutes once FDA posts them, are on FDA's meeting page.
Federal Register notice of Aug 10, 2026 gives the same date. Materials, and the minutes once FDA posts them, are on FDA's meeting page.
6 new medicines recommended for approval, 0 negative opinions on new medicines.
Recommended for approval: Foundayo, Rasonque, Yuviwel, Fovlussea, Neuzafy, Kizfizo
Re-examination outcomes: Yartemlea (negative)
Extensions of indication recommended: Kyinsu, Pandemic influenza vaccine H5N1 AstraZeneca, Talvey, Tryngolza, Tukysa
Source: EMA's highlights of this meeting.
Opinions are usually dated the last day, Nov 12, 2026.
Opinions are usually dated the last day, Dec 10, 2026.
Neutropenia. Reduction of neutropenia in adults
EU/1/26/2066, decision C(2026) 6966. EMA's record still shows the CHMP opinion.
Hypercholesterolemia, Dyslipidemias. Treatment of primary hypercholesterolaemia or mixed dyslipidaemia.
EU/1/26/2056, decision C(2026) 6747. EMA's record still shows the CHMP opinion.
Hypercholesterolemia, Dyslipidemias. It is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-familial) or mixed dyslipidaemia as an adjunct to diet.
EU/1/26/2061, decision C(2026) 6743. EMA's record still shows the CHMP opinion.
Hypertension, Pulmonary, Pulmonary Arterial Hypertension. Treatment of Chronic thromboembolic pulmonary hypertension (CTEPH) in adults and treatment of Pulmonary arterial hypertension (PAH) in adults and children from 6 years of age.
EU/1/26/2059, decision C(2026) 6750. EMA's record still shows the CHMP opinion.
Hypercholesterolemia, Dyslipidemias. Treatment of primary hypercholesterolaemia or mixed dyslipidaemia.
EU/1/26/2055, decision C(2026) 6746. EMA's record still shows the CHMP opinion.
Chemotherapy-Induced Febrile Neutropenia, Neutropenia. Reduction of neutropoenia in adults
EU/1/26/2051, decision C(2026) 5985. EMA's record still shows the CHMP opinion.
Diabetes Mellitus. Treatment of type 2 diabetes mellitus
EU/1/26/2049, decision C(2026) 5964. EMA's record still shows the CHMP opinion.
Liver Cirrhosis, Biliary, Pruritus. Treatment of cholestatic pruritus in adult patients with primary biliary cholangitis.
The decision is not yet published in the Union Register.
Asthma, Nasal Polyps, Urticaria. Treatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU)
Hemophilia A. Prophylaxis of bleeding episodes in patients with haemophilia A
Carcinoma, Non-Small-Cell Lung. The treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
Arthritis, Rheumatoid, Colitis, Ulcerative, Arthritis, Juvenile, Arthritis, Psoriatic, Spondylitis, Ankylosing. Treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis in adults, and juvenile idiopathic arthritis (JIA) in children from 2 years old
Myasthenia Gravis. Treatment of adult patients with generalised myasthemia gravis (gMG)
Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Ovarian Epithelial. Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
Breast Neoplasms. Treatment of breast cancer in adults
Hidradenitis Suppurativa. Treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults
Primary Myelofibrosis, Polycythemia Vera, Graft vs Host Disease. Treatment of myelofibrosis (MF) in adults, treatment of polycythaemia vera (PV) in adults and treatment of Graft versus host disease (GvHD) in adults and children
Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Ovarian Epithelial. Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer
Rabies. Pre-exposure and post-exposure prophylaxis against rabies in all age groups
Short Bowel Syndrome. Treatment of adults with Short Bowel Syndrome
Obesity, Overweight, Diabetes Mellitus. Treatment of obesity and type 2 diabetes mellitus in adults
Wet Macular Degeneration, Macular Edema, Diabetes Complications, Choroidal Neovascularization. Treatment of neovascular (wet) age-related macular degeneration (AMD), and other visual impairments in adults
Glioma. Treatment of adults with glioblastoma multiforme and children with malignant glioma
Neutropenia, Febrile Neutropenia, Chemotherapy-Induced Febrile Neutropenia. Treatment of neutropenia in adults and children
Pancreatic Neoplasms. Treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.
Achondroplasia. Treatment of achondroplasia in children
Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation. Treatment of patients with haemopoietic stem cell transplant-associated thrombotic microangiopathy
EMA's highlights: Jun 25, 2026 negative opinion · Oct 15, 2026 re-examination concluded.
The negative opinion stands after re-examination; the Commission's decision is not yet in EMA's data.
Graft vs Host Disease. Treatment of adult patients with acute-graft-versus-host disease (aGvHD)
EMA's highlights: Jun 25, 2026 negative opinion · Sep 17, 2026 re-examination concluded.
The negative opinion stands after re-examination; the Commission's decision is not yet in EMA's data.
Acute Pain. Treatment of acute pain in children aged 1 to less than 18 years.
EMA's highlights: Jul 23, 2026 negative opinion · Sep 17, 2026 re-examination started.
Re-examination under way; the CHMP gives its final opinion at a later meeting.
Niemann-Pick Diseases. Treatment of Niemann-Pick disease type C (NPC) in patients aged 6 months and older in combination with miglustat.
EMA's highlights: Jul 23, 2026 negative opinion · Sep 17, 2026 re-examination started.
Re-examination under way; the CHMP gives its final opinion at a later meeting.
Sarcoma, Leiomyosarcoma. Treatment of synovial sarcoma or leiomyosarcoma.
EMA's highlights: Jul 23, 2026 negative opinion · Sep 17, 2026 re-examination started.
Re-examination under way; the CHMP gives its final opinion at a later meeting.
