The Front Room

Latest dispatch

SILVER SPRING

JUN 01, 2026

FDA

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

SILVER SPRING

JUN 01, 2026

FDA

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.

MAY 30, 2026

SILVER SPRING

MAY 30, 2026

FDA

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

FDA

Afrezza cleared for pediatric diabetes

FDA approved inhaled insulin Afrezza for children and adolescents aged 6+ with diabetes.

AMSTERDAM

MAY 29, 2026

EMA

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

FDA

Draft guidance issued to reduce animal testing in cancer drug development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

MHRA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

Linzess cleared for pediatric functional constipation

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

SILVER SPRING

MAY 27, 2026

FDA

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

FDA

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

FDA

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

FDA

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

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

FDA

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.

SILVER SPRING

MAY 26, 2026

FDA

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.

MAY 24, 2026

SILVER SPRING

MAY 24, 2026

FDA

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

FDA

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

EMA

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

FDA

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

EMA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

Trimbow cleared for asthma maintenance

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

MAY 15, 2026

LONDON

MAY 15, 2026

MHRA

Beremagene geperpavec cleared for dystrophic epidermolysis bullosa

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

SILVER SPRING

MAY 15, 2026

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

EMA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

EMA

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

EMA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

Caldolor indication expanded

FDA approved an expanded indication for Caldolor (ibuprofen) injection based on Cumberland Pharmaceuticals' application.

SILVER SPRING

APR 16, 2026

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA

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

FDA issues Complete Response Letter for deramiocel

FDA issued a Complete Response Letter for Capricor Therapeutics's deramiocel on 2026-03-10.

SILVER SPRING

MAR 10, 2026

FDA

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.