Regulation
Refine Search
Biotechnology
Last month, the European Commission (EC) approved Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. 21 December 2023
article
Swedish drugmaker Calliditas Therapeutics has received full US Food and Drug Administration approval for Tarpeyo (budesonide), upgrading a previous nod under the Accelerated Approval scheme. 21 December 2023
Pharmaceutical
For a second time, the US Food and Drug Administration has rejected a submission from Merck & Co for approval to market a chronic cough medication. 21 December 2023
Pharmaceutical
Japanese drugmaker Shionogi has launched of siderophore cephalosporin antibiotic Fetroja (cefiderocol) intravenous infusion 1g vial in Japan. 21 December 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday issued the final guidance Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization. 21 December 2023
Generics
The US Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). 20 December 2023
Pharmaceutical
The rare disease unit of Italian drugmaker Chiesi has secured US approval for Filsuvez (birch triterpenes), a new treatment for people with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB). 20 December 2023
Generics
US biotech major Biogen today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of the company’s multiple sclerosis therapy, Tecfidera (dimethyl fumarate). 19 December 2023
Biotechnology
Shares in US biotech Checkpoint Therapeutics slumped by nearly half on Monday. 19 December 2023
Biotechnology
The European Commission has extended the approval of Evkeeza (evinacumab) as an adjunct to diet and other lipid-lowering therapies to treat children aged five to 11 years with homozygous familial hypercholesterolemia (HoFH). 19 December 2023
Biotechnology
The European Commission (EC) has approved two new indications for Keytruda (pembrolizumab). 18 December 2023
Pharmaceutical
Swiss specialty pharma Santhera Pharmaceuticals has announced that Agamree (vamorolone) has been approved in the European Union (EU) to treat Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status. 18 December 2023
Biotechnology
As geopolitical tension intensifies between China and the US-led West, more Chinese biotechs are actively seeking growth opportunities in the vast emerging markets, or the markets outside the USA and European Union, especially the geographically nascent ASEAN region and the wealthy Middle East region. 18 December 2023
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Padcev (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with Keytruda (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally-advanced or metastatic urothelial cancer (la/mUC). 18 December 2023
Pharmaceutical
Hot on the heels of approval from the European regulator, the UK subsidiary of Japan’s Astellas Pharma today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Veoza (fezolinetant). 18 December 2023
Biosimilars
US pharma trade group the Pharmaceutical Research and Manufacturers of America (PhRMA) has offered research suggesting the Inflation Reduction Act (IRA) could undermine the development of biosimilars. 18 December 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended a number of new and generic medicines for approval at its December 2023 meeting. 15 December 2023
Pharmaceutical
Two years after Welireg's (belzutifan) original approval in the rare von Hippel-Lindau (VHL) disease, the Food and Drug Administration has now approved the Merck & Co drug for a new indication. 15 December 2023
Pharmaceutical
Shares in Glaukos Corporation closed more than 25% higher on Thursday. 15 December 2023
Pharmaceutical
Following a broadly positive advisory committee vote in October, the US Food and Drug Administration now approved US WorldMeds, Iwilfin (eflornithine). 15 December 2023
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
The European Commission (EC) has granted marketing authorization for Hympavzi (marstacimab), from US pharma giant Pfizer. 20 November 2024
Pharmaceutical
Ascentage Pharma will see its investigational BCL-2 selective inhibitor, lisaftoclax, assessed under China’s Priority Review scheme. 20 November 2024
Pharmaceutical
Anthony Harnden has been appointed as the new chair of the UK’s Medicine and Healthcare products Regulatory Agency (MHRA). 20 November 2024
Pharmaceutical
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
Pharmaceutical
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
Biosimilars
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
Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). 18 November 2024
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biosimilars
Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze