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Viridian's Lumvoa Approved for Thyroid Eye Disease, Posing Challenge to Amgen's TepezzaRegulatory Approvals

01 Jul 2026

Viridian's Lumvoa Approved for Thyroid Eye Disease, Posing Challenge to Amgen's Tepezza

Viridian Therapeutics received FDA approval for Lumvoa to treat thyroid eye disease, positioning it as a strong competitor to Amgen's Tepezza. Lumvoa offers a...

Amgen’s Tavneos troubles continue as NEJM retracts pivotal publicationRegulatory Approvals

01 Jul 2026

Amgen’s Tavneos troubles continue as NEJM retracts pivotal publication

The New England Journal of Medicine has retracted a pivotal publication for Amgen's rare disease drug, Tavneos, following an ongoing FDA investigation into...

FDA Rejects Unicycive and Sobi Filings Over Contract Manufacturing DeficienciesRegulatory Approvals

01 Jul 2026

FDA Rejects Unicycive and Sobi Filings Over Contract Manufacturing Deficiencies

Unicycive Therapeutics received a second Complete Response Letter (CRL) from the FDA for its drug, oxylanthanum carbonate (OLC), intended for treating...

Imviva Biotech Receives FDA IDE Authorization for clonoSEQ® Assay in TENACITY-01 Clinical TrialRegulatory Approvals

01 Jul 2026

Imviva Biotech Receives FDA IDE Authorization for clonoSEQ® Assay in TENACITY-01 Clinical Trial

Imviva Biotech announced that the U.S. FDA granted Investigational Device Exemption (IDE) authorization for Adaptive Biotechnologies’ clonoSEQ® assay for use...

FDA Hits Praxis with 3-Month Delay for Epilepsy Drug VerdictRegulatory Approvals

01 Jul 2026

FDA Hits Praxis with 3-Month Delay for Epilepsy Drug Verdict

Praxis Precision Medicines' investigational epilepsy therapy, relutrigine, faces a three-month delay in its FDA target decision date. The agency classified...

FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer PatientsRegulatory Approvals

01 Jul 2026

FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients

The U.S. Food and Drug Administration (FDA) has approved Tregzi, a novel allogeneic T-cell-based immunotherapy, for improving chronic graft-versus-host disease...

Viridian debuts on market with FDA greenlight for thyroid eye disease drugRegulatory Approvals

29 Jun 2026

Viridian debuts on market with FDA greenlight for thyroid eye disease drug

Viridian Therapeutics has received FDA approval for its intravenous therapy veligrotug-vvze, branded as Lumvoa, for the treatment of thyroid eye disease (TED)...

REGENXBIO Bets on FDA Flexibility for Duchenne Gene Therapy FilingRegulatory Approvals

25 Jun 2026

REGENXBIO Bets on FDA Flexibility for Duchenne Gene Therapy Filing

REGENXBIO plans to submit a Biologics License Application for its Duchenne muscular dystrophy (DMD) gene therapy, RGX-202, under the accelerated approval...

Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB PsychosisRegulatory Approvals

25 Jun 2026

Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis

Cognition Therapeutics, Inc. announced that it has received written feedback from the U.S. Food and Drug Administration (FDA), confirming alignment on key...

Ascletis receives FDA clearance for Phase I trial of obesity treatmentRegulatory Approvals

25 Jun 2026

Ascletis receives FDA clearance for Phase I trial of obesity treatment

Ascletis Pharma has received Investigational New Drug (IND) clearance from the US FDA to initiate a Phase I study for ASC35, a once-monthly subcutaneous...

Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopeniaRegulatory Approvals

24 Jun 2026

Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia

Sanofi's Wayrilz (rilzabrutinib), an oral reversible Bruton’s tyrosine kinase inhibitor, has received marketing and manufacturing authorization in Japan from...

Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapsesRegulatory Approvals

24 Jun 2026

Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses

Sanofi's Cenrifki (tolebrutinib), an oral Bruton's tyrosine kinase inhibitor, has received European Commission approval for treating secondary progressive...

Orion Pharma’s ODM-212 Granted Orphan Designation for the Treatment of Malignant Mesothelioma by the European CommissionRegulatory Approvals

24 Jun 2026

Orion Pharma’s ODM-212 Granted Orphan Designation for the Treatment of Malignant Mesothelioma by the European Commission

Orion Pharma's investigational drug, ODM-212, has received Orphan Designation from the European Commission for the treatment of malignant mesothelioma, a rare...

REGENXBIO to resubmit application for Hunter gene therapy after FDA’s most recent pivotRegulatory Approvals

22 Jun 2026

REGENXBIO to resubmit application for Hunter gene therapy after FDA’s most recent pivot

REGENXBIO announced that the FDA has reversed its previous stance on the Biologics License Application (BLA) for its Hunter syndrome gene therapy, RGX-121...

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026Regulatory Approvals

19 Jun 2026

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026

The European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) convened from June 16-18, 2026, issuing several key opinions and updates. A...

Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myelomaRegulatory Approvals

19 Jun 2026

Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma

Sanofi's subcutaneous (SC) formulation of Sarclisa (isatuximab) has received approval in Japan from the Ministry of Health, Labour and Welfare for treating...

UniQure Plans Q3 Submission for Huntington's Gene Therapy After FDA ReversalRegulatory Approvals

19 Jun 2026

UniQure Plans Q3 Submission for Huntington's Gene Therapy After FDA Reversal

The FDA has reversed its previous stance, now agreeing to accept uniQure's regulatory filing for its Huntington’s disease gene therapy, AMT-130, based on...

FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphomaRegulatory Approvals

19 Jun 2026

FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination for people with relapsed or refractory large B-cell lymphoma

Roche announced that the US FDA has accepted its supplemental Biologics License Application (sBLA) for subcutaneous Lunsumio VELO (mosunetuzumab) in...

Nicox Announces Positive Pre-submission Regulatory Feedback in China Supporting NDA filing for NCX 470Regulatory Approvals

19 Jun 2026

Nicox Announces Positive Pre-submission Regulatory Feedback in China Supporting NDA filing for NCX 470

Nicox SA announced that its exclusive licensee in China, Ocumension Therapeutics, has received positive pre-submission regulatory feedback from the Chinese...

Teva Submits NDA for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Tourette SyndromeRegulatory Approvals

19 Jun 2026

Teva Submits NDA for Ecopipam, a First-in-Class Investigational Therapy for Pediatric Tourette Syndrome

Teva Pharmaceutical Industries Ltd. announced the submission of a New Drug Application (NDA) to the U.S. FDA for ecopipam, an investigational first-in-class...

GSK, Spero’s oral antibiotic wins first FDA nod for complicated UTIRegulatory Approvals

19 Jun 2026

GSK, Spero’s oral antibiotic wins first FDA nod for complicated UTI

GSK and Spero Therapeutics have received FDA approval for Utebzi (tebipenem pivoxil) for complicated urinary tract infections (cUTIs) caused by susceptible...

UniQure plans Q3 submission for Huntington’s gene therapy after FDA reverses course—againRegulatory Approvals

18 Jun 2026

UniQure plans Q3 submission for Huntington’s gene therapy after FDA reverses course—again

uniQure intends to submit a Biologics License Application (BLA) for its Huntington’s disease gene therapy, AMT-130, in the third quarter. This follows the...

FDA Approves First Single-Dose Generic Treatment for InfluenzaRegulatory Approvals

18 Jun 2026

FDA Approves First Single-Dose Generic Treatment for Influenza

The U.S. Food and Drug Administration has approved the first generic version of Xofluza (baloxavir marboxil) tablets. This single-dose treatment is indicated...

AB Science patent for masitinib in the treatment of metastatic castrate resistant prostate cancer formally granted in the United States with a protection until 2042Regulatory Approvals

18 Jun 2026

AB Science patent for masitinib in the treatment of metastatic castrate resistant prostate cancer formally granted in the United States with a protection until 2042

AB Science announced that the United States Patent Office has formally granted a patent for its lead compound, masitinib, for methods of treating metastatic...

FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid OverdoseRegulatory Approvals

17 Jun 2026

FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

The FDA has approved Rextovy, a 4 mg naloxone hydrochloride nasal spray, for over-the-counter (OTC) emergency treatment of opioid overdose, allowing direct...

FDA, Moderna appear aligned on mRNA flu shot heading into adcommRegulatory Approvals

17 Jun 2026

FDA, Moderna appear aligned on mRNA flu shot heading into adcomm

Moderna's seasonal mRNA flu vaccine, mRNA-1010 (mFLUSIVA), is set for review by the FDA's Vaccines and Related Biological Products Advisory Committee on June...

Intellia’s gene editor ‘keeps pace’ with Ionis in hereditary angioedemaRegulatory Approvals

17 Jun 2026

Intellia’s gene editor ‘keeps pace’ with Ionis in hereditary angioedema

Intellia Therapeutics' CRISPR-based gene editing therapy, lonvoguran ziclumeran (lonvo-z), demonstrated significant efficacy in a Phase 3 HAELO study for...

Sanofi wins type 1 diabetes nod for Tzield after requesting to revoke CNPVRegulatory Approvals

16 Jun 2026

Sanofi wins type 1 diabetes nod for Tzield after requesting to revoke CNPV

Sanofi's antibody therapy Tzield received FDA clearance for pediatric patients aged 8-17 with stage 3 type 1 diabetes, granted via the accelerated pathway....

Roche Receives FDA Approval for First Companion Diagnostic to Assess PTEN Protein in Prostate CancerRegulatory Approvals

12 Jun 2026

Roche Receives FDA Approval for First Companion Diagnostic to Assess PTEN Protein in Prostate Cancer

Roche announced FDA approval for its VENTANA PTEN (SP218) RxDx Assay, the first immunohistochemistry companion diagnostic to identify PTEN protein loss in...

FDA Clears First Over-the-Counter Continuous Glucose Monitor for ChildrenRegulatory Approvals

12 Jun 2026

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

The U.S. Food and Drug Administration (FDA) has cleared Dexcom Inc.'s Stelo Glucose Biosensor System, an integrated continuous glucose monitor (iCGM), for...

Amgen Defends Tavneos' FDA Approval with Duke Data AnalysisRegulatory Approvals

12 Jun 2026

Amgen Defends Tavneos' FDA Approval with Duke Data Analysis

Amgen is challenging an FDA request to voluntarily withdraw its rare inflammatory disease drug, Tavneos, from the market. The FDA raised concerns regarding...

PRAC concludes evaluation of new data regarding potential risk of neurodevelopmental disorders in children born to men treated with valproateRegulatory Approvals

12 Jun 2026

PRAC concludes evaluation of new data regarding potential risk of neurodevelopmental disorders in children born to men treated with valproate

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of new data concerning the potential risk of...

Novo Nordisk: Wegovy® pill (semaglutide tablets) becomes first daily GLP-1 weight-loss pill approved in the UKRegulatory Approvals

11 Jun 2026

Novo Nordisk: Wegovy® pill (semaglutide tablets) becomes first daily GLP-1 weight-loss pill approved in the UK

Novo Nordisk's Wegovy® pill (semaglutide tablets) has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), making it the...

FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and CatsRegulatory Approvals

11 Jun 2026

FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on June 11, 2026, for generic Nitenpyram Tablets to treat New World...

Disc’s FDA meeting sets ‘clear path’ for embattled rare blood disease drugRegulatory Approvals

10 Jun 2026

Disc’s FDA meeting sets ‘clear path’ for embattled rare blood disease drug

Disc Medicine has reached an agreement with the FDA to resubmit its rare blood disorder drug, bitopertin, for erythropoietic protoporphyria. This follows a...

ADA: Lilly bests Novo again, takes GLP-1 pill Foundayo to FDA for diabetes approvalRegulatory Approvals

10 Jun 2026

ADA: Lilly bests Novo again, takes GLP-1 pill Foundayo to FDA for diabetes approval

Eli Lilly's oral GLP-1 drug, Foundayo (orforglipron), demonstrated superior blood sugar control and weight loss compared to competing diabetes drugs, including...

FDA Expands Sunscreen Options for the First Time in 20 YearsRegulatory Approvals

10 Jun 2026

FDA Expands Sunscreen Options for the First Time in 20 Years

The U.S. Food and Drug Administration (FDA) has expanded sunscreen options by adding bemotrizinol to the list of permitted active ingredients for...

Imviva Biotech Receives FDA Investigational New Drug Approval for CTA313, a Dual-Targeted CD19/BCMA Allogeneic CAR-T Cell Therapy for Autoimmune DiseasesRegulatory Approvals

10 Jun 2026

Imviva Biotech Receives FDA Investigational New Drug Approval for CTA313, a Dual-Targeted CD19/BCMA Allogeneic CAR-T Cell Therapy for Autoimmune Diseases

Imviva Biotech announced that the U.S. FDA has cleared its Investigational New Drug (IND) application for CTA313, a dual-targeting CD19/BCMA allogeneic CAR-T...

Innovent eyes third-line nod for gastric cancer ADC on Phase III PFS hitRegulatory Approvals

05 Jun 2026

Innovent eyes third-line nod for gastric cancer ADC on Phase III PFS hit

Innovent Biologics' CLDN18.2-targeting antibody-drug conjugate, arcotatug tavatecan, achieved its primary endpoint of significantly boosting progression-free...

Fulcrum Therapeutics Lays Off 85% of Staff After Discontinuing Sickle Cell AssetRegulatory Approvals

05 Jun 2026

Fulcrum Therapeutics Lays Off 85% of Staff After Discontinuing Sickle Cell Asset

Fulcrum Therapeutics is undergoing a significant restructure, laying off 85% of its workforce, reducing its team to nine employees. This drastic measure...

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