Industry News Drugs.com – New Drug Approvals 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 FDA Approves Awiqli (insulin icodec-abae) as the First and Only Once-Weekly Basal Insulin Treatment for Adults with Type 2 DiabetesMarch 26, 2026 FDA Grants Accelerated Approval for Avlayah (tividenofusp alfa-eknm) for the Treatment of Hunter Syndrome (MPS II)March 25, 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 Wegovy Pill Demonstrated Greater Weight Loss Than Orforglipron and Lower Odds of Stopping Medication Due to Side Effects in a New Indirect Comparison to be Presented at Obesity Medicine Association 2026April 2, 2026 Cocrystal Pharma Receives FDA Fast Track Designation for CDI-988 for Norovirus Infection Treatment and PreventiveApril 2, 2026 Context Therapeutics Announces CTIM-76 Receives FDA Fast Track Designation for the Treatment of Platinum-Resistant Ovarian CancerApril 2, 2026 Vascarta Announces Positive Clinical Trial Results for Topical/Transdermal Curcumin Gel VAS-101 in Knee OsteoarthritisApril 1, 2026 NIH Researchers Discover Pain-Relieving Drug with Minimal Addictive PropertiesApril 1, 2026 FORE Biotherapeutics Receives Breakthrough Therapy Designation for PlixorafenibApril 1, 2026 Efzimfotase Alfa Demonstrated Positive Results From Global Phase III Clinical Programme in HypophosphatasiaMarch 31, 2026 Novo Nordisk Launches First and Only Multi-Month Subscription Program for FDA-Approved Wegovy, Offering Savings of up to $1,200/yearMarch 31, 2026 Merck’s Enlicitide Decanoate, an Investigational Oral PCSK9 Inhibitor, Demonstrated Significantly Greater LDL-C Reductions at Eight Weeks Compared to Guideline-Recommended Oral Non-Statin Therapies When Added to Background StatinsMarch 30, 2026 Novartis IgAN data in New England Journal of Medicine Show Fabhalta Slowed Kidney Function Decline by 49.3%March 29, 2026
