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Pharmaceutical
The US Food and Drug Administration (FDA) has notified Bayer that it has extended the review period for the New Drug Application (NDA) for elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) due to menopause. 26 July 2025
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma today revealed that the US Food and Drug Administration (FDA) has approved Anzupgo (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. 24 July 2025
Biotechnology
US biotech Avidity Biosciences’ stock rose 4% on Wednesday after the company announced that the US Food and Drug Administration (FDA) had granted Breakthrough Therapy designation to delpacibart zotadirsen (del-zota, formerly known as AOC 1044), the company’s investigational therapy for the treatment of people with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44). 24 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for GSK’s Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. 24 July 2025
Biotechnology
French biotech ImCheck Therapeutics has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, in acute myeloid leukemia (AML). 22 July 2025
Biotechnology
Shares in Replimune Group, a US biotech developing novel oncolytic immunotherapies, went in freefall Tuesday, as the company announced a major setback. 22 July 2025
Biotechnology
Shares in Sarepta Therapeutics have slumped by more than a third since late last week amid new updates on its gene therapy development woes. 22 July 2025
Biotechnology
The US regulator has tapped Stanford University physician-scientist and former biotech executive George Tidmarsh to serve as director of its Center for Drug Evaluation and Research, CDER, stepping into a pivotal leadership role during a time of significant internal reshuffling. 22 July 2025
Biosimilars
South Korea’s biosimilar drug developer Samsung Bioepis today released its Third Quarter 2025 Biosimilar Market Report, marking the tenth edition reviewing the situation in the USA. 21 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, submitted by US pharma major Bristol Myers Squibb. 21 July 2025
Pharmaceutical
The Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). 21 July 2025
Biotechnology
As of July 18, 2025, the Food and Drug Administration (FDA) said it has received three reports of fatal acute liver failure following treatment of patients with Sarepta Therapeutics’ AAVrh74 gene therapies that appear to have been caused by the gene therapy products as a result of acute liver failure. 19 July 2025
Biotechnology
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has voted against two proposed combination regimens containing GSK’s Blenrep (belantamab mafodotin), sending shares in the UK drugmaker tumbling by 5% Friday. 18 July 2025
article
A panel of health experts has called on the US regulator to remove boxed warnings from vaginal estrogen treatments, arguing the safety notice is no longer backed by current evidence and discourages patients from accessing effective menopause care. 18 July 2025
Biotechnology
The US Food and Drug Administration (FDA) announced the approval of 127 innovator and biosimilar drugs in 2024, a notable decrease from the 149 approvals recorded in 2023. 17 July 2025
Biotechnology
UK pharma major GSK has gained US regulatory approval for a new prefilled syringe presentation of its shingles vaccine, Shingrix (zoster vaccine), a move aimed at streamlining administration and boosting immunization coverage. 17 July 2025
Biotechnology
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications. 16 July 2025
Biotechnology
The Division of Hepatology and Nutrition of the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase IIa clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH), California, USA-based drug developer Kezar Life Sciences announced yesterday. 16 July 2025
Biosimilars
The US Food and Drug Administration approved, the first rapid-acting interchangeable biosimilar product, Kirsty (insulin aspart-xjhz, as a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novolog (insulin aspart), from Denmark’s Novo Nordisk. 16 July 2025
Pharmaceutical
Germany’s Bayer has announced that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). 14 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has notified Bayer that it has extended the review period for the New Drug Application (NDA) for elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) due to menopause. 26 July 2025
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma today revealed that the US Food and Drug Administration (FDA) has approved Anzupgo (delgocitinib) cream (20 mg/g) for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. 24 July 2025
Biotechnology
US biotech Avidity Biosciences’ stock rose 4% on Wednesday after the company announced that the US Food and Drug Administration (FDA) had granted Breakthrough Therapy designation to delpacibart zotadirsen (del-zota, formerly known as AOC 1044), the company’s investigational therapy for the treatment of people with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44). 24 July 2025
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for GSK’s Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. 24 July 2025
Biotechnology
French biotech ImCheck Therapeutics has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, in acute myeloid leukemia (AML). 22 July 2025
Biotechnology
Shares in Replimune Group, a US biotech developing novel oncolytic immunotherapies, went in freefall Tuesday, as the company announced a major setback. 22 July 2025
Biotechnology
Shares in Sarepta Therapeutics have slumped by more than a third since late last week amid new updates on its gene therapy development woes. 22 July 2025
Biotechnology
The US regulator has tapped Stanford University physician-scientist and former biotech executive George Tidmarsh to serve as director of its Center for Drug Evaluation and Research, CDER, stepping into a pivotal leadership role during a time of significant internal reshuffling. 22 July 2025
Biosimilars
South Korea’s biosimilar drug developer Samsung Bioepis today released its Third Quarter 2025 Biosimilar Market Report, marking the tenth edition reviewing the situation in the USA. 21 July 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis, submitted by US pharma major Bristol Myers Squibb. 21 July 2025
Pharmaceutical
The Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration (FDA) met to discuss the supplemental New Drug Application (sNDA) of Rexulti (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). 21 July 2025
Biotechnology
As of July 18, 2025, the Food and Drug Administration (FDA) said it has received three reports of fatal acute liver failure following treatment of patients with Sarepta Therapeutics’ AAVrh74 gene therapies that appear to have been caused by the gene therapy products as a result of acute liver failure. 19 July 2025
Biotechnology
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has voted against two proposed combination regimens containing GSK’s Blenrep (belantamab mafodotin), sending shares in the UK drugmaker tumbling by 5% Friday. 18 July 2025
article
A panel of health experts has called on the US regulator to remove boxed warnings from vaginal estrogen treatments, arguing the safety notice is no longer backed by current evidence and discourages patients from accessing effective menopause care. 18 July 2025
Biotechnology
The US Food and Drug Administration (FDA) announced the approval of 127 innovator and biosimilar drugs in 2024, a notable decrease from the 149 approvals recorded in 2023. 17 July 2025
Biotechnology
UK pharma major GSK has gained US regulatory approval for a new prefilled syringe presentation of its shingles vaccine, Shingrix (zoster vaccine), a move aimed at streamlining administration and boosting immunization coverage. 17 July 2025
Biotechnology
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications. 16 July 2025
Biotechnology
The Division of Hepatology and Nutrition of the US Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase IIa clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH), California, USA-based drug developer Kezar Life Sciences announced yesterday. 16 July 2025
Biosimilars
The US Food and Drug Administration approved, the first rapid-acting interchangeable biosimilar product, Kirsty (insulin aspart-xjhz, as a 3 mL single-patient-use prefilled pen and 10 mL multiple-dose vial. Kirsty is biosimilar to and interchangeable with Novolog (insulin aspart), from Denmark’s Novo Nordisk. 16 July 2025
Pharmaceutical
Germany’s Bayer has announced that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following the agency’s Priority Review of its supplemental New Drug Application (sNDA). 14 July 2025
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