FDA Calendar

Augmentin XR for bacterial infections requiring extended-release amoxicillin and clavulanate.

Teplizumab for delaying progression to stage 3 type 1 diabetes.

Pergoveris for infertility treatment in assisted reproductive technology.

Ketamine injectable product prioritized for domestic manufacturing resilience and hospital supply.

RMC-6236 for RAS-mutant pancreatic and other solid tumors.

Bitopertin for erythropoietic protoporphyria.

DB-OTO for otoferlin-related congenital hearing loss.

Orforglipron for obesity.

Casgevy for sickle cell disease.

Wegovy for obesity.

Bedaquiline pediatric formulation for pulmonary multidrug-resistant tuberculosis in young children.

Dostarlimab for mismatch repair-deficient locally advanced rectal cancer.

Tabelecleucel for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD)

Cerezyme for treatment of Gaucher disease type 3 (GD3), with expanded labeling for patients with GD1 and GD3 with no age limitation

FDA decision on expanded use of Leniolisib as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome

FDA decision on Anaphylm in the treatment of Type 1 allergic reactions, including anaphylaxis

FDA decision on clemidsogene lanparvovec for the treatment of Mucopolysaccharidosis II (MPS II)

Enlicitide decanoate for hypercholesterolemia.

Sacituzumab tirumotecan for advanced or metastatic EGFR-mutant nonsquamous non-small cell lung cancer.

FDA decision on KEYTRUDA plus chemotherapy with or without bevacizumab for treatment of patients with platinum-resistant recurrent ovarian cancer

FDA decision on Bysanti (milsaperidone) for the acute treatment of bipolar I disorder and the treatment of schizophrenia

FDA decision on INQOVI plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy

FDA decision on ET-600 for the treatment of central diabetes insipidius, also known as arginine vasopressin deficiency

Zongertinib (Hernexeos) for previously treated HER2-mutant non-small cell lung cancer.

FDA decision on TransCon CNP (navepegritide) for the treatment of children with achondroplasia

FDA decision on PALYNZIQ to expand treatment to include adolescents aged 12-17 with phenylketonuria (PKU)

FDA decision on Dupixent in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS)

Tec-Dara (teclistamab and daratumumab) for relapsed or refractory multiple myeloma.

FDA decision on Sotyktu for the treatment of adults with active psoriatic arthritis

FDA decision on new formulation of F18 PSMA-targeted PET imaging agent to determine the presence or absence of PSMA positive lesions in prostate cancer

FDA decision on Reproxalap for the treatment of dry eye disease

FDA decision on expanded use of IMCIVREE for the treatment of acquired hypothalamic obesity

FDA decision on Linerixibat for the treatment of cholestatic pruritus in patients with Primary Biliary Cholangitis

FDA decision on KRESLADI for the treatment of for severe Leukocyte Adhesion Deficiency-I

FDA decision on LNTH-2501 for use with PET imaging for localization of somatostatin receptor-positive neuroendocrine tumors

FDA decision on Tividenofusp alfa for the treatment of Hunter syndrome

FDA decision on KEYTRUDA plus Padcev for the treatment of patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy

FDA decision on PADCEV plus KEYTRUDA for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy

FDA decision on Opdivo plus Chemotherapy combination for previously untreated Stage III or IV Classical Hodgkin Lymphoma

FDA decision on RP1 in combination with Bristol Myers Squibbs Opdivo for the treatment of advanced melanoma

FDA decision on FILSPARI (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS)

FDA decision on subcutaneous Sarclisa in multiple myeloma

FDA decision on GTx-104 for the treatment of aneurysmal Subarachnoid Hemorrhage (aSAH)

FDA decision on Dupixent for the treatment of chronic spontaneous urticaria (CSU) in children

FDA decision on Doravirine/Islatravir, an oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed

FDA decision on Tzield to expand to as young as one year old and above to delay the onset of stage 3 type 1 diabetes

FDA decision on AXS-05 for the treatment of Alzheimers disease agitation

FDA decision on VYVGART with generalized myasthenia gravis who test negative for AChR antibodies (seronegative gMG)

FDA decision on ENHERTU followed by paclitaxel, trastuzumab and pertuzumab for the neoadjuvant treatment of HER2-positive early breast cancer

FDA decision on LEQEMBI IQLIK, as a weekly starting dose, for the treatment of early Alzheimers Disease

FDA decision on Leqembi Iqlik Subcutaneous Autoinjector for the treatment of Alzheimers disease in patients with confirmed amyloid pathology

FDA decision on Afrezza Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes

FDA decision on CTx-1301 for the treatment of Attention-Deficit/Hyperactivity Disorder in children, adolescents, and adults

FDA decision on Vepdegestrant for the treatment of ESR1m, ER+/HER2- advanced breast cancer

FDA decision on Oclaiz for the treatment of patients with acromegaly

Intranasal cenegermin-bkbj for nonarteritic anterior ischemic optic neuropathy.

Cytisinicline for smoking cessation.

FDA decision on Nanoencapsulated Sirolimus plus Pegadricase (NASP) to treat uncontrolled gout

FDA decision on Oxylanthanum Carbonate for the treatment of hyperphosphatemia in CKD patients on dialysis

FDA decision on ZORYVE cream 0.3% to expand indication for the topical treatment of plaque psoriasis in patients 6 years and older

FDA decision on Veligrotug for the Treatment of Thyroid Eye Disease

FDA decision on atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN)

FDA decision on Relacorilant as a treatment for patients with platinum-resistant ovarian cancer

FDA decision on gedatolisib in hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA wild-type advanced breast cancer

FDA decision on Centanafadine for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults

FDA decision on FUROSCIX ReadyFlow Autoinjector for the Treatment of Edema in adults with Chronic Heart Failure or Chronic Kidney Disease

FDA decision on KETAFREE, a preservative-free intravenous ketamine formulation

FDA decision on low dose estrogen weekly patch for contraception

FDA decision on MK-6240, a PET Imaging Agent, for the detection of tau neurofibrillary tangle (NFT) pathology in patients with cognitive impairment being evaluated for Alzheimers disease

FDA decision on ropeginterferon alfa-2b-njft for the treatment of adult patients with essential thrombocythemia

FDA decision on Zidesamtinib for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer in adults

FDA decision on INO-3107 for the treatment of adults with Recurrent Respiratory Papillomatosis