The Docket

Viridian Therapeutics — Lumvoa (veligrotug-vvze) $VRDN

for Thyroid eye disease (active and chronic)

BLA

FDA approved Viridian's Lumvoa (veligrotug-vvze) — an anti-IGF-1R monoclonal antibody — for thyroid eye disease in adults. First TED therapy with a label covering both active (early inflammatory) and chronic (post-inflammatory fibrotic) stages of the disease. Supported by the THRIVE and THRIVE-2 pivotal trials — the largest pivotal trials ever conducted in TED.

Bayer — Ambelvist (gadoquatrane) $BAYRY

for MRI contrast enhancement (CNS and non-CNS body regions)

NDA

FDA approved Ambelvist (gadoquatrane) for contrast-enhanced MRI to detect lesions with abnormal vascularity in the CNS and non-CNS body regions. Dosed at 0.01 mmol/kg — the lowest-dose macrocyclic gadolinium-based contrast agent approved in the United States.

Haisco Pharmaceutical Group — Cypsedo (cipepofol)

for Induction and maintenance of general anesthesia; procedural sedation

NDA

FDA approved Cypsedo (cipepofol) injection for induction and maintenance of general anesthesia. Cipepofol is a short-acting GABA-A positive allosteric modulator ~4-6× more potent than propofol, and Cypsedo is the first China-originated innovative intravenous anesthetic to receive FDA marketing authorization.

Shionogi & Co., Ltd. — Xocova (ensitrelvir) $SGIOY

for COVID-19 post-exposure prophylaxis

NDA

FDA approved Xocova (ensitrelvir) as the first oral option for post-exposure prophylaxis of COVID-19, expanding the preventive toolkit beyond vaccines and the high-risk-only monoclonal antibody pemivibart.

Wockhardt Ltd. — Zaynich (cefepime/zidebactam)

for complicated urinary tract infections

NDA

FDA approved Zaynich (cefepime + zidebactam) for adults with complicated urinary tract infections. Wockhardt's first FDA approval — gives clinicians a novel beta-lactam-enhancer combination for multidrug-resistant gram-negative cUTI.

MannKind Corporation — Afrezza (insulin human (inhalation powder)) $MNKD

for diabetes mellitus in children and adolescents aged 6 and older

sNDA

FDA approved expanded labelling for Afrezza (inhaled insulin) to include children and adolescents aged 6 and older with diabetes. Afrezza becomes the first and only inhaled mealtime insulin approved for this pediatric population, offering a needle-free option alongside existing injection and pump regimens.

AstraZeneca — Imfinzi (durvalumab) $AZN

for BCG-naïve, high-risk non-muscle-invasive bladder cancer

BLA

FDA approved AstraZeneca's Imfinzi in combination with BCG induction and maintenance therapy for BCG-naïve, high-risk non-muscle-invasive bladder cancer.

Johnson & Johnson — Tremfya (guselkumab) $JNJ

for active psoriatic arthritis — prevention of further joint damage

sBLA

FDA approved a supplemental BLA expanding Tremfya's label to include prevention of further joint damage in adults with active psoriatic arthritis, based on data showing slowed structural damage progression. Cements Tremfya as the only IL-23 inhibitor with this specific labelling claim.

AbbVie — pivekimab sunirine $ABBV

for relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN)

BLA · Priority Review · Orphan · Breakthrough

Ironwood Pharmaceuticals — Linzess (linaclotide) $IRWD

for Functional constipation

NDA

FDA approved Linzess (linaclotide) for pediatric patients aged 2+ with functional constipation.

Daiichi Sankyo — Datroway (datopotamab deruxtecan-dlnk)

for unresectable or metastatic triple-negative breast cancer

BLA

FDA approved Datroway for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

Gilead Sciences — Hepcludex (bulevirtide-gmod) $GILD

for Chronic hepatitis delta virus (HDV) infection

BLA

FDA approved Hepcludex (bulevirtide-gmod) injection — the first treatment for chronic hepatitis delta virus infection — in adults without cirrhosis or with compensated cirrhosis.

AstraZeneca — Baxfendy (baxdrostat) $AZN

for uncontrolled or resistant hypertension

NDA · Priority Review

FDA approved Baxfendy as the first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in adults whose blood pressure is not adequately controlled on other antihypertensives. Approval establishes the ASI class commercially and creates the competitive bar for Mineralys's lorundrostat (also tracking in this Docket).

Chiesi USA, Inc. — Trimbow (beclomethasone/formoterol/glycopyrrolate)

for maintenance treatment of asthma

NDA

FDA approved Trimbow (beclomethasone/formoterol/glycopyrrolate) inhaler for maintenance treatment of asthma.

Daiichi Sankyo — Enhertu (fam-trastuzumab deruxtecan-nxki) $DSKYF

for HER2-positive breast cancer

BLA

FDA approved Enhertu for two new indications in HER2-positive breast cancer patients in neoadjuvant and adjuvant settings.

Genentech — Tecentriq (atezolizumab) $RHHBY

for muscle-invasive bladder cancer

BLA

FDA approved Genentech's Tecentriq for adjuvant treatment of muscle-invasive bladder cancer using ctDNA-guided therapy.

Krystal Biotech — Vyjuvek (beremagene geperpavec) $KRYS

for dystrophic epidermolysis bullosa

BLA

MHRA approved beremagene geperpavec (Vyjuvek) for the treatment of dystrophic epidermolysis bullosa.

AstraZeneca — Fasenra (benralizumab) $AZN

for Hypereosinophilic Syndrome

BLA

FDA approved AstraZeneca's Fasenra for adult and pediatric patients aged 12+ with hypereosinophilic syndrome without an identifiable non-hematologic cause.

BeOne Medicines — Beqalzi (sonrotoclax) $ONC

for relapsed or refractory mantle cell lymphoma

NDA · Priority Review · Accelerated Approval

FDA granted accelerated approval to Beqalzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma. The drug enters a category currently led by AbbVie's Venclexta (venetoclax); the differentiation is centered on BCL2 selectivity and the dosing profile.

Taiho Oncology, Inc. — Inqovi (decitabine/cedazuridine)

for acute myeloid leukemia ineligible for intensive induction chemotherapy

NDA

FDA approved Inqovi (decitabine/cedazuridine) plus venetoclax for acute myeloid leukemia patients ineligible for intensive induction chemotherapy.

argenx SE — Vyvgart (efgartigimod) $ARGX

for generalized myasthenia gravis — all adult patients (label expansion)

sBLA · Standard Review

FDA approved label expansion for Vyvgart and Vyvgart Hytrulo to cover all adult patients with generalized myasthenia gravis (gMG), broadening eligibility beyond the previously approved anti-AChR antibody-positive subset. Approval lands ~2 months ahead of the assigned PDUFA, materially expanding the addressable population.

Genentech — Ocrevus (ocrelizumab) $RHHBY

for relapsing-remitting multiple sclerosis

BLA

FDA approved Ocrevus (ocrelizumab) IV infusion for relapsing-remitting multiple sclerosis in pediatric patients aged 10 and older.

Partner Therapeutics — Bizengri (zenocutuzumab-zbco)

for NRG1 fusion-positive cholangiocarcinoma

BLA

FDA granted approval to Partner Therapeutics' Bizengri (zenocutuzumab-zbco) for NRG1 fusion-positive cholangiocarcinoma under the FDA Commissioner's National Priority Voucher (CNPV) pilot program — the seventh CNPV approval. Same drug received the CNPV award on 2026-05-06; approval landed 2 days later.

Hetero USA — Ennumo (pegfilgrastim-pccg)

for decrease incidence of infection in patients receiving myelosuppressive chemotherapy

BLA

FDA approved Ennumo (pegfilgrastim-pccg) as a biosimilar to Neulasta, adding another lower-cost option for managing chemotherapy-induced neutropenia. Approval follows the standard 351(k) biosimilar pathway.

Vanda Pharmaceuticals — Nereus (tradipitant) $VNDA

for motion sickness

NDA · Standard Review

FDA approved Nereus (tradipitant) for motion sickness on May 4, 2026 — the first new pharmacologic treatment for motion sickness in over 40 years. Distinct program from Vanda's tradipitant gastroparesis NDA which received a CRL earlier.

Arvinas — Veppanu (vepdegestrant) $ARVN

for ESR1-mutated ER+/HER2− advanced or metastatic breast cancer after prior endocrine therapy

NDA · Standard Review

FDA approved Veppanu (vepdegestrant) — the first PROTAC heterobifunctional protein degrader — for ESR1-mutated ER+/HER2− advanced breast cancer after prior endocrine therapy. Approval landed ~5 weeks ahead of the assigned PDUFA date. Pivotal data from VERITAC-2 vs. fulvestrant supported the filing.

Incyte — Jakafi XR (ruxolitinib (extended-release)) $INCY

for myelofibrosis, polycythemia vera, and graft-versus-host disease

sNDA · Standard Review

FDA approved Jakafi XR — once-daily extended-release ruxolitinib — across the three approved Jakafi indications (myelofibrosis, polycythemia vera, graft-versus-host disease). Approval lands ~2 months ahead of PDUFA and extends Incyte's franchise as the IR formulation approaches loss of exclusivity.

Axsome Therapeutics — Auvelity (dextromethorphan/bupropion) $AXSM

for Agitation in Alzheimer's dementia

NDA

FDA approved Auvelity (dextromethorphan/bupropion) for agitation associated with dementia due to Alzheimer's disease.

AstraZeneca — Saphnelo (anifrolumab) $AZN

for systemic lupus erythematosus

BLA

FDA approved AstraZeneca's Saphnelo Pen autoinjector for once-weekly subcutaneous self-administration in adult SLE patients.

Johnson & Johnson — Caplyta (lumateperone) $JNJ

for schizophrenia

NDA

FDA approved a supplemental New Drug Application for Caplyta (lumateperone) based on long-term data supporting reduced relapse risk in schizophrenia.

Regeneron Pharmaceuticals — Otarmeni (lunsotogene parvec-cwha) $REGN

for Genetic hearing loss

BLA

FDA approved Regeneron's Otarmeni (lunsotogene parvec-cwha), the first-ever gene therapy treatment for genetic hearing loss, under the FDA Commissioner's National Priority Voucher (CNPV) pilot program.

Sanofi and Regeneron — Dupixent (dupilumab)

for chronic spontaneous urticaria in children

BLA

FDA approved Dupixent (dupilumab) for children aged two to 11 years with chronic spontaneous urticaria who remain symptomatic despite antihistamine treatment.

Merck — Idvynso (doravirine/islatravir) $MRK

for HIV-1 infection in virologically suppressed adults (maintenance regimen)

NDA · Standard Review

FDA approved Idvynso (doravirine/islatravir) on April 20, 2026 — ahead of the May 10 2026 PDUFA target. Once-daily oral two-drug single-tablet regimen for adults with virologically-suppressed HIV-1. First NRTTI-containing complete regimen; positioned as a maintenance alternative to integrase-inhibitor backbones (Biktarvy, Dovato).

Johnson & Johnson — Stelara (ustekinumab) $JNJ

for Pediatric Crohn's disease (ages 2 and older)

sBLA

FDA approved ustekinumab (Stelara) for patients aged two years and older with moderately to severely active Crohn's disease — pediatric label expansion of an already-marketed biologic.

Rocket Pharmaceuticals — Kresladi (marnetegragene autotemcel) $RCKT

for severe leukocyte adhesion deficiency type I (LAD-I)

BLA · Priority Review · Orphan · RMAT

FDA approved Kresladi at/near the April 14, 2026 PDUFA date — the first gene therapy approved for severe LAD-I and a platform validation for Rocket's lentiviral technology. Sponsor monetized the resulting Priority Review Voucher for $180M shortly after approval (April 28, 2026).

Travere Therapeutics — Filspari (sparsentan) $TVTX

for focal segmental glomerulosclerosis

NDA

FDA approved Filspari (sparsentan) to reduce proteinuria in adult and pediatric patients with focal segmental glomerulosclerosis.

Kite — Tecartus (brexucabtagene autoleucel)

for relapsed or refractory mantle cell lymphoma

BLA

FDA granted full approval to Kite's CAR T-cell therapy Tecartus for adult patients with relapsed or refractory mantle cell lymphoma.

Eli Lilly — Foundayo (orforglipron) $LLY

for chronic weight management in adults with obesity or overweight with weight-related conditions

NDA · Commissioner's National Priority Voucher (CNPV)

FDA approved Foundayo (orforglipron) on April 1, 2026 — approved under the Commissioner's National Priority Voucher (CNPV) Pilot Program just 50 days after filing. Fastest approval of a new molecular entity since 2002. First oral non-peptide GLP-1 agonist; can be taken daily without food or water restrictions (differentiated from oral semaglutide / Rybelsus). ATTAIN-1 showed weight loss up to 12.4% at 72 weeks. T2D filing planned later in 2026 based on ACHIEVE program.

Vertex Pharmaceuticals Incorporated — Alyftrek, Trikafta (vanzacaftor/tezacaftor/deutivacaftor, elexacaftor/tezacaftor/ivacaftor) $VRTX

for cystic fibrosis

NDA

FDA approved expanded use of Alyftrek and Trikafta for cystic fibrosis treatment, increasing availability to ~95% of patients.

Novo Nordisk — Awiqli (insulin icodec-abae) $NVO

for type 2 diabetes — once-weekly basal insulin

NDA · Standard Review

FDA approved Awiqli (insulin icodec-abae) 700 units/mL on March 27, 2026 — ~2 months ahead of the projected May 29 PDUFA. First and only once-weekly basal insulin for adults with type 2 diabetes, reducing basal injections from seven to one per week. Based on ONWARDS Phase 3a programme. Nationwide US launch expected 2H 2026.

Corcept Therapeutics — Lifyorli (relacorilant) $CORT

for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (combination with nab-paclitaxel; ≥1 prior regimen incl. bevacizumab)

NDA · Standard Review

FDA approved Lifyorli (relacorilant) plus nab-paclitaxel on March 25, 2026 — more than three months ahead of the Jul 10 2026 PDUFA target. First FDA-approved selective glucocorticoid receptor antagonist (SGRA). Indicated for adults with platinum-resistant ovarian / fallopian tube / primary peritoneal cancer who have received 1–3 prior systemic regimens, at least one including bevacizumab. Based on positive Phase 3 ROSELLA OS+PFS data.

Denali Therapeutics — Avlayah (tividenofusp alfa) $DNLI

for Hunter syndrome (MPS II)

BLA · Priority Review · Orphan · Accelerated Approval

FDA approved Avlayah (tividenofusp alfa-eknm) on March 25, 2026 for the treatment of Hunter syndrome (MPS II) — ~2 weeks ahead of the extended Apr 7 PDUFA. First validation of Denali's enzyme transport vehicle (ETV) brain-shuttle technology in a commercial approval; opens read-through to the broader CNS-ERT pipeline (MPS IIIA, MPS IIIB, Parkinson's LRRK2).

Johnson & Johnson — Icotyde (icotrokinra) $JNJ

for moderate-to-severe plaque psoriasis (adults and adolescents ≥12 yrs, ≥40 kg)

NDA · Standard Review

FDA approved Icotyde (icotrokinra) on March 18, 2026 — ahead of the Jul 21 2026 PDUFA target. First and only targeted oral peptide IL-23 receptor antagonist; first-line systemic therapy for moderate-to-severe plaque psoriasis. Adolescent inclusion (≥12 yrs, ≥40 kg) distinguishes it from injectable comparators.

Milestone Pharmaceuticals — Cardamyst (etripamil) $MIST

for paroxysmal supraventricular tachycardia (PSVT) — on-demand nasal spray

NDA · Standard Review

FDA approved Cardamyst (etripamil) nasal spray on or near the March 11, 2026 PDUFA date. First patient-administered acute PSVT therapy. Sponsor Watch confirms commercial launch with Q1 2026 revenue (below initial analyst expectations); RESET-PSVT real-world evidence registry is in the works.

Ascendis Pharma — Yuviwel (navepegritide) $ASND

for achondroplasia in children aged 2 years and older with open epiphyses

NDA · Priority Review · Orphan

FDA granted accelerated approval to Yuviwel (navepegritide) on February 27, 2026 — three days ahead of the extended Mar 2 2026 PDUFA target. First and only once-weekly treatment indicated to increase linear growth in children aged 2 yrs and older with achondroplasia (open epiphyses). Rare Pediatric Disease Priority Review Voucher issued.

Eton Pharmaceuticals — Desmoda (desmopressin acetate oral solution) $ETON

for central diabetes insipidus (arginine vasopressin deficiency) — patients of all ages

NDA · Standard Review

FDA approved Desmoda (desmopressin acetate) Oral Solution on February 25, 2026 — on the assigned PDUFA target date. First and only FDA-approved oral liquid formulation of desmopressin; supports precise individualized dosing without tablet splitting, crushing, refrigeration, mixing, or shaking. Commercial launch expected March 9, 2026. Eton estimates ~13,000 US patients (~3,000-4,000 pediatric) with peak sales potential $30-50M annually.

Vanda Pharmaceuticals — Bysanti (milsaperidone) $VNDA

for schizophrenia and bipolar disorder (acute treatment)

NDA · Standard Review

FDA approved Bysanti (milsaperidone) on February 20, 2026 — two weeks ahead of the Mar 5 2026 PDUFA target. Approved for acute manic/mixed episodes of bipolar I disorder and for schizophrenia in adults. Milsaperidone is a new chemical entity that rapidly interconverts to iloperidone, providing dual active molecules acting on D2/5-HT2A/α1 receptors. Commercial availability expected Q3 2026.

Cytokinetics — Myqorzo (aficamten) $CYTK

for obstructive hypertrophic cardiomyopathy (HCM)

NDA · Standard Review

FDA approved Myqorzo (aficamten) on December 19, 2025 — ~1 week ahead of the extended PDUFA — for adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Second-in-class cardiac myosin inhibitor after BMS's Camzyos (mavacamten). Available in 5/10/15/20 mg doses.

Crinetics Pharmaceuticals — Palsonify (paltusotine) $CRNX

for acromegaly

NDA · Standard Review · Orphan

FDA approved Palsonify as the first oral somatostatin analog for acromegaly, displacing once-monthly injectable somatostatin analogs (Sandostatin LAR, Somatuline Depot) for many patients.

Stealth BioTherapeutics — Forzinity (elamipretide) $STEA

for Barth syndrome (muscle strength in adults and pediatric patients ≥30 kg)

NDA · Priority Review · Orphan · Accelerated Approval

FDA granted accelerated approval to Forzinity (elamipretide) on September 19, 2025 — just ~1 month after Class 2 resubmission acceptance, well ahead of the projected Feb 15 2026 PDUFA. First-ever approved therapy for Barth syndrome and the first FDA-approved therapy for any mitochondrial disease. Approval based on improved knee extensor muscle strength (intermediate clinical endpoint) from TAZPOWER trial.

Insmed — Brinsupri (brensocatib) $INSM

for non-cystic fibrosis bronchiectasis

NDA · Priority Review · Breakthrough · Orphan

FDA approved Brinsupri as the first targeted therapy for non-CF bronchiectasis, addressing a population of ~350,000 US patients previously managed with macrolide antibiotics and supportive care.

KalVista Pharmaceuticals — Ekterly (sebetralstat) $KALV

for hereditary angioedema (HAE) — on-demand treatment (ages 12+)

NDA · Priority Review · Orphan

FDA approved Ekterly (sebetralstat) on July 2, 2025 — ~2 weeks after the missed June 17 PDUFA goal date. First and only oral on-demand treatment approved for HAE attacks in adults and pediatric patients ages 12+. The KONFIDENT Phase 3 trial supported the application.