The Docket

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.

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.

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.

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).

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 — 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 — 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.

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.

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.

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.

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.

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.