Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting.The committee…, CHMP statistics Key figures from the December 2025 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new

Original title: “Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025”

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of…

Original title: “New medicine to treat non-muscle invasive bladder cancer”

The Food and Drug Administration (FDA or Agency) has determined that LUNELLE (estradiol cypionate and medroxyprogesterone acetate) injectable, 5 milligrams (mg)/0.5 milliliter (mL) estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for estradiol cypionate and medroxyprogesterone acetate injectable, 5 mg/0.5 mL estradiol cypionat

Original title: “Determination That LUNELLE (Estradiol Cypionate and Medroxyprogesterone Acetate) Injectable, 5 Milligrams/0.5 Milliliter and 25 Milligrams/0.5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Original title: “Pfizer Inc., U.S. Agent for King Pharmaceuticals LLC, et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications”

The U.S. Food and Drug Administration today approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS).

Original title: “FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome”

The U.S. Food and Drug Administration today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program, marking the first approval achieved through this review pathway.

Original title: “First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity”

The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA).

Original title: “FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia”

CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation from Elanco GmbH for Varenzin (molidustat), for the…, Maximum residue limits Lidocaine (Porcine) - Summary opinion of the CVMP on the…

Original title: “Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 2-4 December 2025”

The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S.

Original title: “FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US”

Today, the U.S. Food and Drug Administration conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution for the prevention and treatment of New World screwworm (NWS) larval infestations, and the treatment and control of cattle fever tick in beef cattle 2 months of age and older and repl

Original title: “FDA Conditionally Approves Topical Drug for Cattle for New World Screwworm and Cattle Fever Tick”

The U.S. Food and Drug Administration today granted approval for Avance (acellular nerve allograft-arwx) in surgical implantation.

Original title: “FDA Approves Nerve Scaffold for the Treatment of Sensory Nerve Discontinuity”

The FDA has approved Novartis’ intrathecal formulation of onasemnogene abeparvovec-brve, marketed as Itvisma, for patients ages 2 years and older living with spinal muscular atrophy. "Itvisma is the first IT AAV9 gene therapy approved, but treatments for many other diseases using AAV9, or variants of AAV9, will soon follow. Itvisma’s approval opens the door for an exciting era of definitive treatments for neurological disorders with genetic features." STEER, a 52-week study, comprised 126 treatment-naïve patients with SMA Type 2 who were randomly assigned 1:1 to either Itvisma or sham procedure, followed by a crossover phase. In the trial, those on the intrathecal medication demonstrated a statistically significant 2.39-point improvement on HFMSE vs 0.51 points for those on sham (P = .0074). STEER, the most notable of the trials, met its primary end point, as treatment with the intrathecal formulation led to significant enhancements in motor function, assessed through total Hammersmith Functional Motor Scale-Expanded (HFMSE) scores. "Itvisma is the first systemic gene therapy available to a large population of adults, so many providers and institutions that care for adults will have their first experience with this revolutionary treatment modality. This trial included 23 sitting, nonambulatory patients with SMA testing three dose levels across two age groups (6 to <24 months and 24 to <60 months). After 12 months, older patients in the medium-dose cohort (1.2 x 10¹⁴ vg) showed significant improvements in HFMSE scores compared with historical controls, reaching roughly twice the accepted minimal clinically meaningful difference (P <.01).3 STRENGTH differed slightly from STEER in that it tested safety, tolerability, and efficacy of the intrathecal medication in patients with SMA who discontinued previously approved treatments nusinersen (Spinraza; Biogen) or risdiplam (Evrysdi; Genentech). The open-label, single-arm study included 27 patients with a mean age of 7.4 years and were on risdiplam or nusinersen for a mean duration of 2.98 and 4.32 years, respectively. ... Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, Itvisma continued to maintain a similar safety profile that was observed in STEER.

Original title: “FDA Approves New Intrathecal Administration Route for Spinal Muscular Atrophy Gene Therapy | NeurologyLive - Clinical Neurology News and Neurology Expert Insights”

The U.S. Food and Drug Administration today approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in the survival motor neuron 1 (SMN1) gene.

Original title: “FDA Approves Gene Therapy for Treatment of Spinal Muscular Atrophy”

This news announcement was updated on 20 November 2025 to correct the list of frequently reported adverse reactions. , EMA has recommended granting a marketing authorisation in the European Union (EU) for Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes in adults and…

Original title: “First-in-class treatment to delay onset of type 1 diabetes”

The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of th

Original title: “FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury”

Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its November 2025 meeting.The committee recommended…, CHMP statistics , CHMP statistics:…, Positive recommendations on new medicines, Dawnzera International non-proprietary name (INN) doni

Original title: “Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 November 2025”

In response to a request from the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration (FDA) yesterday issued an Emergency Use Authorization (EUA) for the Trioplex Real-time RT-PCR Assay, a diagnostic tool for Zika virus that will be distributed to qualified laboratories.

Original title: “New CDC Laboratory Test for Zika Virus Authorized for Emergency Use by FDA - Media Statement”

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Original title: “Ebola vaccine trial begins in Sierra Leone - Press Release”

A senior CDC health official will give an overview of the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). CDC is launching the trial in partnership with the Sierra Leone College of Medicine and Allied Health Sciences and the Ministry of Health and Sanitation.

Original title: “Launch of STRIVE Ebola Vaccine Trial - Media Advisory”

On December 16, 2013 CDC was informed by Merck that the company planned to implement a voluntary recall of one lot (lot J007354) of Gardasil® [Human Papillomavirus Quadrivalent (types 6, 11, 16, and 18) Vaccine, Recombinant], due to the potential for a small number of vials to contain glass particles as a result of breakage during the manufacturing process. These vials were distributed between August 20, 2013, and October 9, 2013. No other lots are affected.

Original title: “Voluntary Recall of One Lot of Gardasil HPV Vaccine - Media Statement”