Regulation

Refine Search

China's regulator to review Akeso's checkpoint blocker

Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024

Amid RFK Jr vaccine worries, FDA’s Peter Marks remains calm

The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024

FDA panel flags risks as AstraZeneca seeks full Andexxa approval

British pharma major AstraZeneca is facing challenges in its bid to secure full approval for its anticoagulant reversal therapy, Andexxa (andexanet alfa), in the USA. 22 November 2024

FDA approves Jazz’s Ziihera for HER2+ biliary tract cancer

The US Food and Drug Administration (FDA) has granted accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use, say the drug’s developer, Jazz Pharmaceuticals. 21 November 2024

Astellas’ loss is Apellis’ gain as FDA setback shakes up prospects

Astellas Pharma has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol). 21 November 2024

EC approval for Pfizer’s Hympavzi

The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024

Ascentage's lisaftoclax accepted for priority review in China

Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024

Former GP to chair UK’s MHRA

Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024

TGA safety warning on promethazine

Australia’s Therapeutic Goods Administration (TGA) yesterday warned that health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under six years of age. 20 November 2024

EC grants approval for AbbVie’s Elahere in ovarian cancer

19 November 2024

MHRA approves Filspari for IgAN

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday approved the medicine Filspari (sparsentan) from Vifor France to treat primary immunoglobulin A nephropathy (IgAN). 19 November 2024

Opuviz is latest EC-approved ophthalmology biosimilar

Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024

Junshi gains UK nod for Loqtorzi in two cancer indications

Shanghai-based Junshi Biosciences has received UK regulatory approval for Loqtorzi (toripalimab) in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). 18 November 2024

FDA accepts Dupixent sBLA resubmission for CSU

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024

Research concerns remain as Denmark targets care reform

The Danish government’s newly-unveiled health reform has been praised for tackling chronic disease care and health inequalities while driving health innovation. 18 November 2024

Syndax earns its 2nd drug approval in 2024 with Revuforj

The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024

J&J seeks court's blessing for controversial rebate plan

Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024

UK regulator approves adapted Novavax jab

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Novavax’s Nuvaxovid jab targeting the latest subvariant. 15 November 2024

EMA/CHMP November recommendations include Leqembi U-turn

The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024

AlveoGene wins RPDD from FDA for AVG-002

Oxford, UK-based rare respiratory diseases focused AlveoGene today revealed it has been granted a Rare Pediatric Disease designation (RPDD) by the US Food and Drug Administration (FDA) for AVG-002, its novel, inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency. 15 November 2024

12 3 4 5 6 7 8 9 10 Next page

Lilly's Alzheimer’s drug Kisunla wins FDA approval

The US Food and Drug Administration (FDA) approved Eli Lilly’s Kisunla (donanemab-azbt), once-monthly injection for IV infusion), Alzheimer's treatment . 3 July 2024

First COPD nod could add billions to Dupixent revenue

The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD). 3 July 2024

China approval for Xtandi as prostate cancer therapy

China’s Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved Japanese pharma major Astellas’ Xtandi (enzalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 2 July 2024

Sobi initiates rolling biologics license application to FDA for SEL-212

Swedish Orphan Biovitrum, also known as Sobi, today announced the initiation of a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for SEL-212. 2 July 2024

EC approves Obgemsa for overactive bladder

Pierre Fabre revealed that the European Commission (EC) has authorized the marketing of its Obgemsa (vibegron) for the symptomatic treatment of overactive bladder syndrome in adults. 2 July 2024

Boosting crinecerfont, Neurocrine draws from gamut of FDA support

In the USA, two New Drug Applications (NDA) for crinecerfont have been accepted by the US regulator, and will be considered under the Priority Review scheme. 1 July 2024

Collaboration with pharma on the up in Belgium

pharma.be, the umbrella organization of innovative biopharma companies active in Belgium, has highlighted the publication of the Transparency Register 2023. 1 July 2024

EC vaccine approval maintains Valneva’s pursuit of chikungunya virus

Specialty vaccine company Valneva has announced that the European Commission (EC) has granted marketing authorization for its single-dose vaccine, Ixchig, for the prevention of disease caused by the chikungunya virus in people aged 18 years of and older. 1 July 2024

FDA greenlight for Samsung Bioepis’ biosimilar to Stelara

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe) submitted by South Korean firm Samsung Bioepis. 1 July 2024

Sipavibart closer to offering COVID-19 protection to immunocompromised in Europe

AstraZeneca’s Marketing Authorization Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. 1 July 2024

China's quantity and quality of innovative drugs joins global lead

China has approved 82 innovative drugs and 138 innovative medical devices since 2022, a health official said on Friday (June 28). 1 July 2024

Latin America studies the adoption of regulatory reliance

Latin American countries have taken on the task of exploring how a tool such as regulatory reliance can be better used to improve health ecosystems in the region, based on trust and teamwork, without having to complete their own thorough reviews that demand time and resources. 1 July 2024

FDA slaps CRL on Rocket Pharma’s Kresladi

Late-stage US biotech Rocket Pharmaceutical’s shares slumped 12.5% in pre-market activity, but closed down just 2% at $21.10 on Friday after it announced a setback regarding approval of its gene therapy Kresladi (marnetegragene autotemcel; marne-cel). 29 June 2024

J&J moves Rybrevant into first-line setting with full EU approval

Johnson & Johnson (NYSE: JNJ) has received a new European approval for a combination of Rybrevant (amivantamab) plus chemotherapy in lung cancer. 28 June 2024

EMA/CHMP June 2024 meeting highlights

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines and one biosimilar for approval at its June 2024 meeting. 28 June 2024

FDA opens doors for more treatments for rare diseases

The US Food and Drug Administration (FDA) said on Thursday that it is at a turning point in understanding the science that is opening doors to rare disease treatments that were unthinkable only a few 28 June 2024

FDA nod for Verona's Ohtuvayre could 'change treatment paradigm for COPD'

Shares in Verona Pharma closed nearly 7% higher on Wednesday. 27 June 2024

FDA issues CRL on patritumab deruxtecan BLA

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan (HER3-DXd). 27 June 2024

Bad start for Moderna’s first marketed therapy outside COVID-19

It was a milestone achievement when Moderna last month announced its first US Food and Drug Administration (FDA) approval outside COVID-19. 27 June 2024

FDA approves Genmab and AbbVie’s Epkinly

The US Food and Drug Administration (FDA) has approved US pharma major AbbVieand Denmark’s Genmab Epkinly (epcoritamab-bysp) 27 June 2024

Previous page 13 14 15 161718 19 20 21 22 Next page

Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze