SILVER SPRING
JUN 01, 2026
Xocova cleared for COVID-19 post-exposure prophylaxis
FDA approved Xocova (ensitrelvir) for post-exposure prophylaxis of COVID-19, marking the first oral option for this indication.
Latest dispatch
SILVER SPRING
JUN 01, 2026
ODAC to review camizestrant, Truqap indications
FDA's Oncologic Drugs Advisory Committee will discuss AstraZeneca's camizestrant NDA and Truqap sNDA for breast and prostate cancer indications on April 30, 2026.
/ oncology
DATELINE HEADLINE
JUN 01, 2026
MAY 30, 2026
SILVER SPRING
MAY 30, 2026
Zaynich cleared for complicated urinary tract infections
FDA approved Zaynich (cefepime and zidebactam) for adults with complicated urinary tract infections.
MAY 29, 2026
SILVER SPRING
MAY 29, 2026
Afrezza cleared for pediatric diabetes
FDA approved inhaled insulin Afrezza for children and adolescents aged 6+ with diabetes.
AMSTERDAM
MAY 29, 2026
COVID-19 vaccines recommended for XFG variant targeting
EMA’s Emergency Task Force recommends updating COVID-19 vaccines to target the XFG variant for the 2026/2027 vaccination campaign.
SILVER SPRING
MAY 29, 2026
Draft guidance issued to reduce animal testing in cancer drug development
FDA proposes streamlined nonclinical safety studies for oncology biologics and conjugated products, aiming to reduce unnecessary animal testing.
LONDON
MAY 29, 2026
Rilzabrutinib authorised for immune thrombocytopenia
MHRA grants marketing authorisation for rilzabrutinib to treat adults with immune thrombocytopenia when prior therapies are insufficient.
MAY 28, 2026
SILVER SPRING
MAY 28, 2026
Imfinzi cleared for BCG-naïve high-risk non-muscle-invasive bladder cancer
FDA approved AstraZeneca's Imfinzi in combination with BCG induction and maintenance therapy for BCG-naïve, high-risk non-muscle-invasive bladder cancer.
MAY 27, 2026
SILVER SPRING
MAY 27, 2026
Boxed Warning removed for canagliflozin amputation risk
FDA removed the Boxed Warning about leg and foot amputation risk from canagliflozin (Invokana) labeling based on new clinical trial data showing enhanced heart and kidney benefits.
SILVER SPRING
MAY 27, 2026
Boxed warnings updated for JAK inhibitors Xeljanz, Olumiant, Rinvoq
FDA required revisions to the Boxed Warning for Xeljanz, Olumiant, and Rinvoq to include risks of serious heart-related events, cancer, blood clots, and death based on a safety clinical trial.
SILVER SPRING
MAY 27, 2026
Clozapine REMS program eliminated
FDA removed the REMS program for clozapine, no longer requiring ANC blood test reporting but maintaining monitoring recommendations.
SILVER SPRING
MAY 27, 2026
Linzess cleared for pediatric functional constipation
FDA approved Linzess (linaclotide) for pediatric patients aged 2+ with functional constipation.
SILVER SPRING
MAY 27, 2026
Pivekimab sunirine-pvzy cleared for blastic plasmacytoid dendritic cell neoplasm
FDA approved pivekimab sunirine-pvzy for adults with blastic plasmacytoid dendritic cell neoplasm based on CADENZA trial results.
SILVER SPRING
MAY 27, 2026
Statin pregnancy contraindication removed
FDA requested removal of the contraindication against statin use during pregnancy, allowing individualized benefit-risk decisions for high-risk patients.
SILVER SPRING
MAY 27, 2026
Xeljanz safety trial flags heart, cancer risks
FDA alerts public to preliminary findings of increased heart-related events and cancer risk with Xeljanz compared to TNF inhibitors.
MAY 26, 2026
SILVER SPRING
MAY 26, 2026
Boxed Warning update mandated for benzodiazepines
FDA requires updated Boxed Warnings and prescribing information for all benzodiazepines to address risks of abuse, addiction, dependence, and withdrawal.
SILVER SPRING
MAY 26, 2026
FDA warns against unapproved GLP-1 compounds
FDA cautions against using unapproved compounded versions of GLP-1 drugs like semaglutide and tirzepatide due to safety and quality concerns.
SILVER SPRING
MAY 26, 2026
REMS lifted for endothelin receptor antagonists
FDA removed REMS requirements for embryofetal toxicity risk from ambrisentan, macitentan-containing products, and aprocitentan, citing sufficient risk communication through labeling.
SILVER SPRING
MAY 26, 2026
Rare Disease Drug Development Guidance Updated
FDA updates guidance documents on rare disease drug development, covering topics from natural history studies to accelerated approval pathways.
MAY 24, 2026
SILVER SPRING
MAY 24, 2026
Differin Epiduo Acne Gel cleared for nonprescription use
FDA approved Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for over-the-counter treatment of acne.
MAY 22, 2026
SILVER SPRING
MAY 22, 2026
Datopotamab deruxtecan-dlnk approved for triple-negative breast cancer
FDA cleared datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer.
AMSTERDAM
MAY 22, 2026
Eight medicines recommended for approval by CHMP
EMA's CHMP recommended eight medicines for approval, including Jascayd, Boey, Etcamah, and Vijoice, at its May 2026 meeting.
SILVER SPRING
MAY 22, 2026
Hepcludex cleared for chronic hepatitis delta virus
FDA approved Hepcludex (bulevirtide-gmod) injection for chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis.
AMSTERDAM
MAY 22, 2026
Jascayd recommended for idiopathic pulmonary fibrosis
EMA recommended marketing authorisation for Jascayd (nerandomilast) to treat idiopathic pulmonary fibrosis and other fibrotic lung diseases.
MAY 21, 2026
SILVER SPRING
MAY 21, 2026
CSL Behring Warning Letter issued
FDA issued a Warning Letter to CSL Behring for advertising and promotional labeling violations.
MAY 19, 2026
SILVER SPRING
MAY 19, 2026
Asundexian NDA accepted under priority review
FDA accepted Bayer's NDA for Factor XIa inhibitor asundexian for prevention of thromboembolic events.
SILVER SPRING
MAY 19, 2026
Warning Letter issued to Naseem A. Jaffrani
FDA issued a Warning Letter to clinical investigator Naseem A. Jaffrani for violations identified during an inspection.
SILVER SPRING
MAY 19, 2026
Warning Letter issued to Sourav K. Mishra
FDA issued a Warning Letter to Sourav K. Mishra, M.D. regarding deficiencies in bioavailability-bioequivalence studies.
MAY 18, 2026
SILVER SPRING
MAY 18, 2026
Baxfendy cleared as first aldosterone synthase inhibitor for hypertension
FDA approved AstraZeneca's Baxfendy (baxdrostat) as the first aldosterone synthase inhibitor for hypertension in combination with other antihypertensive medications.
SILVER SPRING
MAY 18, 2026
Immgolis Intri cleared as interchangeable biosimilar to Simponi Aria
FDA approved Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar to Simponi Aria (golimumab).
SILVER SPRING
MAY 18, 2026
Immgolis cleared as interchangeable biosimilar to Simponi
FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar to Simponi for Accord BioPharma.
SILVER SPRING
MAY 18, 2026
Trimbow cleared for asthma maintenance
FDA approved Trimbow (beclomethasone/formoterol/glycopyrrolate) inhaler for maintenance treatment of asthma.
MAY 15, 2026
LONDON
MAY 15, 2026
Beremagene geperpavec cleared for dystrophic epidermolysis bullosa
MHRA approved beremagene geperpavec (Vyjuvek) for the treatment of dystrophic epidermolysis bullosa.
SILVER SPRING
MAY 15, 2026
Enhertu cleared for HER2-positive breast cancer
FDA approved Enhertu for two new indications in HER2-positive breast cancer patients in neoadjuvant and adjuvant settings.
SILVER SPRING
MAY 15, 2026
Tecentriq cleared for adjuvant bladder cancer with ctDNA guidance
FDA approved Genentech's Tecentriq for adjuvant treatment of muscle-invasive bladder cancer using ctDNA-guided therapy.
MAY 14, 2026
SILVER SPRING
MAY 14, 2026
Crysvita dosing update approved for XLH
FDA approved a dosing update for Crysvita (burosumab-twza) in adults with X-linked hypophosphatemia.
SILVER SPRING
MAY 14, 2026
Fasenra cleared for Hypereosinophilic Syndrome
FDA approved AstraZeneca's Fasenra for adult and pediatric patients aged 12+ with hypereosinophilic syndrome without an identifiable non-hematologic cause.
MAY 13, 2026
SILVER SPRING
MAY 13, 2026
Beqalzi cleared for relapsed or refractory mantle cell lymphoma
FDA granted accelerated approval to Beqalzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma.
SILVER SPRING
MAY 13, 2026
Inqovi plus venetoclax cleared for AML ineligible for intensive chemo
FDA approved Inqovi (decitabine/cedazuridine) plus venetoclax for acute myeloid leukemia patients ineligible for intensive induction chemotherapy.
MAY 08, 2026
SILVER SPRING
MAY 08, 2026
Bizengri cleared for NRG1 fusion-positive cholangiocarcinoma
FDA approved Bizengri (zenocutuzumab-zbco) for NRG1 fusion-positive cholangiocarcinoma under the National Priority Voucher Pilot Program.
SILVER SPRING
MAY 08, 2026
Ocrevus cleared for pediatric multiple sclerosis
FDA approved Ocrevus (ocrelizumab) IV infusion for relapsing-remitting multiple sclerosis in pediatric patients aged 10 and older.
SILVER SPRING
MAY 08, 2026
Postapproval pregnancy safety studies guidance finalized
FDA issued final guidance on methodologies for postapproval pregnancy safety studies of drugs and biologics.
SILVER SPRING
MAY 08, 2026
Vyvgart and Vyvgart Hytrulo expanded for generalized myasthenia gravis
FDA approved Vyvgart and Vyvgart Hytrulo for all adult patients with generalized myasthenia gravis.
MAY 07, 2026
AMSTERDAM
MAY 07, 2026
2026/2027 seasonal flu vaccine strains recommended
EMA issued recommendations for egg-derived and live-attenuated influenza vaccine strains for the 2026/2027 season.
MAY 06, 2026
SILVER SPRING
MAY 06, 2026
National Priority Voucher awarded for Zenocutuzumab
FDA awarded a Commissioner’s National Priority Voucher to Partner Therapeutics for Zenocutuzumab in NRG1 fusion-positive cholangiocarcinoma.
MAY 01, 2026
SILVER SPRING
MAY 01, 2026
Jakafi XR cleared for myelofibrosis, polycythemia vera, GVHD
FDA approved Jakafi XR (ruxolitinib) extended-release tablets for myelofibrosis, polycythemia vera, and graft-versus-host disease in adults.
SILVER SPRING
MAY 01, 2026
Veppanu cleared for ESR1m, ER+/HER2- advanced breast cancer
FDA approved Veppanu (vepdegestrant) for the treatment of ESR1m, ER+/HER2- advanced breast cancer.
APR 30, 2026
SILVER SPRING
APR 30, 2026
Asceniv label expanded for pediatric immune-compromised patients
FDA approved an expanded indication for Asceniv to include pediatric immune-compromised patients aged two years and older.
SILVER SPRING
APR 30, 2026
Auvelity cleared for agitation in Alzheimer's dementia
FDA approved Auvelity (dextromethorphan/bupropion) for agitation associated with dementia due to Alzheimer's disease.
SILVER SPRING
APR 30, 2026
TAVNEOS approval withdrawal proposed
FDA proposes to withdraw approval of ChemoCentryx's TAVNEOS (avacopan) due to lack of substantial evidence and material misstatements in the application.
APR 29, 2026
SILVER SPRING
APR 29, 2026
Langlara cleared as interchangeable biosimilar to Lantus
FDA approved Langlara (insulin glargine-aldy) as an interchangeable biosimilar to Lantus for diabetes treatment.
APR 28, 2026
SILVER SPRING
APR 28, 2026
Real-time clinical trials initiative advances
FDA announced two major steps to implement real-time clinical trials as part of a broader initiative to modernize trial conduct.
APR 27, 2026
SILVER SPRING
APR 27, 2026
Caplyta sNDA approved for schizophrenia relapse risk reduction
FDA approved a supplemental New Drug Application for Caplyta (lumateperone) based on long-term data supporting reduced relapse risk in schizophrenia.
SILVER SPRING
APR 27, 2026
Saphnelo Pen cleared for SLE self-administration
FDA approved AstraZeneca's Saphnelo Pen autoinjector for once-weekly subcutaneous self-administration in adult SLE patients.
APR 24, 2026
AMSTERDAM
APR 24, 2026
CHMP recommends approval for tolebrutinib, onasemnogene abeparvovec, plozasiran
EMA's CHMP issued positive opinions for Sanofi's tolebrutinib, Novartis' onasemnogene abeparvovec, and Arrowhead's plozasiran across three indications.
AMSTERDAM
APR 24, 2026
Redemplo recommended for familial chylomicronaemia syndrome
EMA recommended granting marketing authorisation for Redemplo (plozasiran) to treat adults with familial chylomicronaemia syndrome.
APR 23, 2026
SILVER SPRING
APR 23, 2026
Gene therapy Otarmeni cleared for genetic hearing loss
FDA approved Otarmeni, a dual AAV vector-based gene therapy, for genetic hearing loss under the National Priority Voucher Program.
APR 22, 2026
SILVER SPRING
APR 22, 2026
Dupixent cleared for pediatric chronic spontaneous urticaria
FDA approved Dupixent (dupilumab) for children aged two to 11 years with chronic spontaneous urticaria who remain symptomatic despite antihistamine treatment.
SILVER SPRING
APR 22, 2026
Tzield indication expanded to pediatric type 1 diabetes
FDA approved Tzield (teplizumab-mzwv) for delaying stage 3 type 1 diabetes onset in children as young as one year old.
APR 21, 2026
SILVER SPRING
APR 21, 2026
Idvynso cleared for HIV-1 in adults
FDA approved Idvynso, a two-drug single-tablet regimen of doravirine and islatravir, for HIV-1 treatment in adults.
APR 16, 2026
SILVER SPRING
APR 16, 2026
Caldolor indication expanded
FDA approved an expanded indication for Caldolor (ibuprofen) injection based on Cumberland Pharmaceuticals' application.
SILVER SPRING
APR 16, 2026
Testosterone therapy indication exploration for low libido
FDA invites sponsors of approved testosterone replacement therapies to discuss potential new indications for low libido in men with idiopathic hypogonadism.
APR 15, 2026
LANGHORNE
APR 15, 2026
Molgramostim BLA review period extended
FDA extended the review period for Savara's Molgramostim Inhalation Solution BLA in autoimmune pulmonary alveolar proteinosis.
SILVER SPRING
APR 15, 2026
Stelara cleared for pediatric Crohn’s disease
FDA approved ustekinumab for patients aged two years and older with moderately to severely active Crohn’s disease.
APR 14, 2026
SILVER SPRING
APR 14, 2026
Genome editing safety standards draft guidance issued
FDA released draft guidance on safety standards for genome editing technologies in human gene therapy product development.
APR 13, 2026
SILVER SPRING
APR 13, 2026
Filspari approved for focal segmental glomerulosclerosis
FDA approved Filspari (sparsentan) to reduce proteinuria in adult and pediatric patients with focal segmental glomerulosclerosis.
APR 09, 2026
SILVER SPRING
APR 09, 2026
Vabysmo label updated for macular edema treatment extension
FDA approved an updated label for Vabysmo (faricimab-svoa) to extend treatment duration for macular edema following retinal vein occlusion beyond six months.
APR 02, 2026
SILVER SPRING
APR 02, 2026
Eylea HD dosing interval extended to 5 months
FDA approved extended dosing intervals up to 5 months for Eylea HD (aflibercept) in wet age-related macular degeneration and diabetic macular edema.
SILVER SPRING
APR 02, 2026
Tecartus cleared for relapsed or refractory mantle cell lymphoma
FDA granted full approval to Kite's CAR T-cell therapy Tecartus for adult patients with relapsed or refractory mantle cell lymphoma.
APR 01, 2026
SILVER SPRING
APR 01, 2026
Alyftrek and Trikafta label expansions approved for cystic fibrosis
FDA approved expanded use of Alyftrek and Trikafta for cystic fibrosis treatment, increasing availability to ~95% of patients.
SILVER SPRING
APR 01, 2026
Orforglipron approved under National Priority Voucher Program
FDA approved orforglipron as the first new molecular entity under the Commissioner's National Priority Voucher pilot program.
MAR 31, 2026
SILVER SPRING
MAR 31, 2026
Ponlimsi approved as Prolia biosimilar
FDA cleared Ponlimsi (denosumab-adet) as a biosimilar to Prolia for osteoporosis treatment.
MAR 30, 2026
SILVER SPRING
MAR 30, 2026
High-dose Spinraza regimen approved for spinal muscular atrophy
FDA approved a high-dose regimen of Spinraza (nusinersen) for spinal muscular atrophy.
MAR 27, 2026
SILVER SPRING
MAR 27, 2026
Kresladi granted accelerated approval for LAD-I
FDA granted accelerated approval to Rocket Pharmaceuticals' Kresladi for pediatric patients with severe leukocyte adhesion deficiency-I.
SILVER SPRING
MAR 27, 2026
Neffy label updated to remove age restriction
FDA approved removal of the age requirement from the Neffy (epinephrine nasal spray) label, expanding its use across all age groups.
MAR 26, 2026
SILVER SPRING
MAR 26, 2026
Awiqli cleared for Type 2 diabetes
FDA approved Awiqli (insulin icodec-abae) as the first once-weekly basal insulin treatment for adults with Type 2 diabetes.
MAR 25, 2026
SILVER SPRING
MAR 25, 2026
Avlayah granted accelerated approval for Hunter syndrome
FDA granted accelerated approval to Denali Therapeutics' Avlayah (tividenofusp alfa-eknm) for the treatment of Hunter syndrome (MPS II).
SILVER SPRING
MAR 25, 2026
Lifyorli plus nab-paclitaxel cleared for platinum-resistant ovarian cancer
FDA approved Lifyorli (relacorilant) in combination with nab-paclitaxel for platinum-resistant ovarian cancer.
MAR 10, 2026
SILVER SPRING
MAR 10, 2026
FDA lifts deramiocel CRL, resumes BLA review
FDA lifted its previously issued Complete Response Letter for Capricor Therapeutics' deramiocel BLA and accepted the resubmission as a Class 2 with a PDUFA target action date of August 22, 2026.
SILVER SPRING
MAR 10, 2026
FDA issues Complete Response Letter for deramiocel
FDA issued a Complete Response Letter for Capricor Therapeutics's deramiocel on 2026-03-10.
FEB 23, 2026
SILVER SPRING
FEB 23, 2026
Molbreevi BLA filed for autoimmune pulmonary alveolar proteinosis
FDA accepted Savara's BLA for Molbreevi in autoimmune pulmonary alveolar proteinosis for review.
FEB 13, 2026
SILVER SPRING
FEB 13, 2026
Bitopertin CRL issued for EPP
FDA issued a Complete Response Letter to Disc Medicine for bitopertin in erythropoietic protoporphyria.
FEB 02, 2026
SILVER SPRING
FEB 02, 2026
Complete Response Letter issued for Anaphylm
FDA issued a Complete Response Letter to Aquestive Therapeutics for Anaphylm, citing deficiencies in the NDA.