Industry News Drugs.com – New Drug Approvals Cumberland Pharmaceuticals Announces Expanded Indication for Caldolor (ibuprofen) InjectionApril 16, 2026 Travere Therapeutics Announces Full FDA Approval of Filspari (sparsentan), the First and Only Approved Medicine for Focal Segmental Glomerulosclerosis (FSGS)April 13, 2026 U.S. FDA Grants Full Approval of Kite’s Tecartus for Adult Patients with Relapsed or Refractory Mantle Cell LymphomaApril 2, 2026 Eylea HD (aflibercept) Approved by FDA as First and Only Injectable Anti-VEGF with Dosing Intervals Up to 5 Months for Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME)April 2, 2026 FDA Approves Foundayo (orforglipron), the Only GLP-1 Pill for Weight Loss That Can be Taken Any Time of Day Without Food or Water RestrictionsApril 1, 2026 Vertex Announces US FDA Approval for Label Extensions of Alyftrek and Trikafta, Expanding Availability of These Medicines to ~95% of All People With CF in the United StatesApril 1, 2026 FDA Approves Ponlimsi (denosumab-adet), a Biosimilar to ProliaMarch 31, 2026 FDA Approves New High Dose Regimen of Spinraza (nusinersen) for Spinal Muscular AtrophyMarch 30, 2026 ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy 1 mg (epinephrine nasal spray) LabelMarch 27, 2026 FDA Grants Accelerated Approval for Kresladi for the Treatment of Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I)March 27, 2026 Drugs.com – New Drug Applications Replimune Receives Complete Response Letter from the FDA for RP1 Biologics License Application for the Treatment of Advanced MelanomaApril 10, 2026 Nuvalent Announces Submission of New Drug Application to FDA for Neladalkib in TKI Pre-treated Advanced ALK-Positive NSCLCApril 7, 2026 Ultragenyx Announces U.S. FDA Acceptance of BLA Resubmission for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)April 2, 2026 Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic MalignanciesApril 1, 2026 Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)April 1, 2026 Elevar Therapeutics Announces FDA Acceptance for Review of New Drug Application for Lirafugratinib as Second-line Cholangiocarcinoma TreatmentMarch 30, 2026 Egetis Announces FDA Acceptance and Priority Review of NDA for Emcitate (tiratricol) for MCT8 DeficiencyMarch 27, 2026 Ionis Announces Zilganersen New Drug Application for Alexander Disease (AxD) Accepted by FDA for Priority ReviewMarch 17, 2026 Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye DiseaseMarch 17, 2026 Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)March 16, 2026 Drugs.com – Clinical Trials News ESCMID: Sanofi’s NUVAXOVID™ COVID-19 Vaccine Showed Better Tolerability Than mNEXSPIKE in Head-to-Head StudyApril 18, 2026 ACHIEVE-4, the Longest Phase 3 Study of Lilly's Foundayo (orforglipron) to Date, Reaffirmed its Cardiovascular and Overall Safety ProfileApril 16, 2026 Astellas Doses First Patient in Phase 3 Study of Setidegrasib (ASP3082) for KRAS G12D-Mutated Metastatic Pancreatic Ductal AdenocarcinomaApril 15, 2026 Lilly's Jaypirca (pirtobrutinib) Significantly Extended Progression-Free Survival When Added to a Venetoclax Time-Limited Regimen in Patients with Previously Treated CLL/SLLApril 13, 2026 Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based ChemotherapyApril 13, 2026 NIH-Funded Breakthrough Shrinks CRISPR for Precision Delivery in the BodyApril 13, 2026 GSK Presents Positive Data for B7-H4-Targeted ADC Mocertatug Rezetecan in Gynecological CancersApril 12, 2026 AbbVie Showcases Late‑Breaking Phase 2 Data for Mirvetuximab Soravtansine-gynx (Elahere) in Platinum‑Sensitive Ovarian Cancer (PSOC) at SGO 2026April 12, 2026 Corcept Presents Complete Data from Pivotal ROSELLA Trial in SGO Late-Breaker with Simultaneous Publication in The Lancet: Lifyorli (relacorilant) Plus Nab-Paclitaxel Improves Overall Survival in Patients with Platinum-Resistant Ovarian CancerApril 10, 2026 Amgen Announces Positive Topline Phase 3 Results for Subcutaneous Tepezza in Adults Living With Moderate-to-Severe Active Thyroid Eye DiseaseApril 6, 2026
