EMA

CHMP gives nod for Sanofi’s Cenrifki for multiple sclerosis

Fri, 24 Apr 2026 12:00:00 -0400

Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.

Roche plots route to EMA approval for DMD gene therapy

Fri, 17 Apr 2026 12:00:00 -0400

Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy.

EMA poised to approve first NAM to replace live animal controls in toxicity tests

Thu, 02 Apr 2026 12:00:00 -0400

The EMA has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. While limited in scope, this is the first time the EMA has formally endorsed the use of a new approach methodology (NAM) to generate data that could eventually be included in an application for marketing approval.

US FDA warns of liver injuries, 8 deaths associated with Tavneos

Wed, 01 Apr 2026 12:00:00 -0400

Once again, Amgen Inc.’s Tavneos (avacopan) is under U.S. FDA scrutiny, as the agency alerted patients and doctors March 31 about 76 cases of drug-induced liver injury, including eight deaths, with “reasonable evidence of a causal association” with the drug.

EMA to withdraw approval for Siga’s tecovirimat in treating mpox

Fri, 27 Mar 2026 12:00:00 -0400

As expected, the EMA is recommending withdrawal of the mpox indication for Siga Technologies Inc.’s tecovirimat, whilst maintaining its approval as a treatment for smallpox, cowpox and adverse reactions to vaccinia vaccines.

Cbio’s novoleucel cleared for clinic for cervical cancer

Thu, 12 Mar 2026 09:00:00 -0400

Cbio A/S has received European regulatory clearance to begin a first-in-human trial of novoleucel, the company’s next-generation T-cell therapy, in late-stage cervical cancer. The phase I/IIa study will enroll patients with persistent or recurrent cervical cancer at Karolinska University Hospital.

Moderna’s combo flu/COVID vaccine gets thumbs up in EU

Fri, 27 Feb 2026 12:00:00 -0500

The EMA’s Committee for Medicinal Products for Human Use recommended approval of Moderna Inc.’s Mcombriax (mRNA-1083), positioning it to potentially become the world’s first combination vaccine for both seasonal influenza and COVID-19.

Affinia’s AFTX-201 designated EU orphan drug

Thu, 19 Feb 2026 08:00:00 -0500

Affinia Therapeutics Inc.’s AFTX-201 has been awarded orphan drug designation by the EMA for BAG3-associated dilated cardiomyopathy.

Human-relevant models lining up to replace animal tests

Thu, 12 Feb 2026 12:00:00 -0500

The pressure to replace animal testing with human-relevant assays that are more predictive of human-drug responses has now reached a tipping point, and there is a movement toward greater acceptance of these potentially more translatable tests.

EMA reviewing Amgen’s vasculitis drug over trial ‘data integrity’

Fri, 30 Jan 2026 12:00:00 -0500

The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the vasculitis treatment in January 2022.

Abbott's Tactiflex gains CE mark

Tue, 20 Jan 2026 11:00:00 -0500

Abbott Laboratories received CE mark in Europe for the Tactiflex Duo ablation catheter to treat patients with atrial fibrillation. The first commercial cases using Tactiflex Duo, a dual energy device, were completed in the EU this week.

EMA marks 2025 2nd busiest year, says pace will continue in 2026

Thu, 15 Jan 2026 12:00:00 -0500

The EMA had its second busiest year ever in 2025, approving 104 drugs, of which 38 had a new active substance. Sixteen of these are for treating rare diseases, and four are advanced therapy medicinal products.

EMA gets to work on implementing new EU pharmaceutical rules

Mon, 05 Jan 2026 12:00:00 -0500

After welcoming the political agreement on the EU pharmaceutical legislation in December 2025, the EMA says it will be devoting 2026 to “intense preparation” for its implementation.

Patient deaths prompt halt in Merck-Daiichi phase III in lung cancer

Tue, 23 Dec 2025 00:00:00 -0500

Daiichi Sankyo Inc. told BioWorld it voluntarily placed a partial hold in recruitment and enrollment in the phase III IDeate-Lung02 study of antibody-drug conjugate ifinatamab deruxtecan because of a higher than anticipated incidence of grade 5 interstitial lung disease events. The company did not say how many deaths there had been.

Patient deaths prompt halt in Merck-Daiichi phase III in lung cancer

Fri, 19 Dec 2025 12:00:00 -0500

EU agrees to pharma legislation, but the industry isn’t happy

Mon, 15 Dec 2025 12:00:00 -0500

The EU finally reached agreement on an update of the 20-year-old pharmaceutical legislation, more than five years after the EU Commission first put forward the case for reform and following two and a half years of negotiations on the new rules.

CHMP recommends Immunitybio's Anktiva, Cytokinetics' Myqorzo

Fri, 12 Dec 2025 12:00:00 -0500

The EMA’s Committee for Medicinal Products for Human Use (CHMP) is joining the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in approving Anktiva (nogapendekin alfa inbakicept-pmin) in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to immune stimulation treatment with Bacillus Calmette-Guérin (BCG) vaccine and would otherwise require surgical removal of the bladder.

Avencell’s AVC-203 cleared for clinic for B-cell malignancies

Fri, 05 Dec 2025 08:00:00 -0500

Avencell Therapeutics Inc. has received clinical trial clearances from the FDA and EMA to conduct a phase I/II trial (Quadvance) of AVC-203 for the treatment of relapsed or refractory B-cell malignancies.

Boston Sci's Farapoint secures CE mark

Mon, 01 Dec 2025 11:00:00 -0500

Proving its latest addition to the Farapulse pulsed field ablation (PFA) platform is no turkey, Boston Scientific Corp.'s Farapoint PFA catheter received CE mark as the U.S. celebrated Thanksgiving. Farapoint is indicated for ablation of the cavotricuspid isthmus, specifically to treat right atrial flutter.

Kedrion’s aceruloplasminemia treatment designated EU orphan drug

Fri, 28 Nov 2025 08:00:00 -0500

Kedrion SpA’s investigational plasma-derived treatment for congenital aceruloplasminemia has been awarded European orphan drug designation by the EMA. The company is working to advance this treatment toward clinical development in Europe.

Charity bringing to EU market gene therapy spurned by pharma

Fri, 14 Nov 2025 12:00:00 -0500

Fifteen years since the first patient was treated, and after being ditched by two companies, the EMA is recommending approval of Waskyra (etuvetidigene autotemcel), the first gene therapy for treating Wiskott-Aldrich syndrome.

Proqr’s AX-0810 gains European clinical trial clearance

Tue, 21 Oct 2025 09:00:00 -0400

Proqr Therapeutics NV has received clinical trial application (CTA) authorization under the EMA’s new centralized review process for a phase I study of AX-0810, which is being developed for the treatment of cholestatic diseases such as primary sclerosing cholangitis and biliary atresia.

Mixed EMA news for Sanofi: Wayrilz yay, Rezurock nay

Fri, 17 Oct 2025 11:00:00 -0400

There was a curate’s egg for Sanofi SA from this month’s meeting of the EMA’s Committee for Medicinal Products for Human Use, with a recommendation to approve one of the French pharma’s drugs – and the rejection of another.

Taho submits US NDA for first apixaban oral dissolving film

Tue, 07 Oct 2025 11:00:00 -0400

Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.

Taho submits US NDA for first apixaban oral dissolving film

Thu, 02 Oct 2025 11:00:00 -0400

US FDA clears ‘one-minute’ Keytruda SC injection for solid tumors

Tue, 23 Sep 2025 11:00:00 -0400

The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.

US FDA clears ‘one-minute’ Keytruda SC injection for solid tumors

Mon, 22 Sep 2025 11:00:00 -0400

CHMP recommends EU approval of Bayer’s Lynkuet for hot flashes

Fri, 19 Sep 2025 11:00:00 -0400

Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzanetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes.

Stakeholders already sounding off on EC review of device regs

Tue, 09 Sep 2025 12:00:00 -0400

The European Commission (EC) posted a call for evidence regarding its intent to “simplify EU rules” for medical technology with a comment period that began Sept. 8, 2025. Stakeholders almost immediately flooded the docket with recommendations.

Europe approves Bio-Thera’s Stelara biosimilar

Tue, 02 Sep 2025 11:00:00 -0400

Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.