The Center for Drug Evaluations of the National Medical Products Administration (NMPA) in China has accepted the biologics license application (BLA) for zanidatamab for second-line treatment of HER2-positive biliary tract cancer (BTC). 11 June 2024
The US Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee yesterday unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer’s disease. 11 June 2024
Genfit, a biopharmaceutical company focused on rare liver diseases, has announced that it has received an Accelerated Approval for Iqirvo (elafibranor). 11 June 2024
The US Food and Drug Administration issued a Federal Register Notice announcing the Emerging Drug Safety Technology Meeting (EDSTM) program, which will be administered through the Center for Drug Evaluation and Research’s (CDER) newly established Emerging Drug Safety Technology Program (EDSTP). 11 June 2024
Calico Life Sciences, a biotech company specializing in aging and age-related diseases, has had its candidate fosigotifator accepted into the US Food and Drug Administration’s Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program. 10 June 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bimzelx (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 10 June 2024
British pharma major AstraZeneca's bid to broaden the label for Tagrisso (osimertinib) will be considered under the Priority Review scheme. 10 June 2024
The US Food and Drug Administration (FDA) has approved the recent supplemental New Drug Application (sNDA), submitted by Spanish dermatology focused drugmaker Almirall, to expand the use area for its drug Klisyri (tirbanibulin) to up to 100 cm. 10 June 2024
The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. 10 June 2024
Swiss pharma giant Roche (ROG: SIX) has announced that the European Commission (EC) has approved Alecensa (alectinib) monotherapy, as adjuvant treatment following tumor resection for adults with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence. 10 June 2024
In a blog post, the general counsel of European trade group EFPIA - the European Federation of Pharmaceutical Industries and Associations - has argued for effective incentives to be included in the EU general pharmaceutical legislation. 10 June 2024
The Chinese National Medical Products Administration (NMPA) held a meeting recently to carry out the 2023 annual review of the vaccine regulatory quality management system (QMS). 10 June 2024
The US Food and Drug Administration (FDA) is to hold an advisory committee meeting on Monday to discuss whether data support a favorable benefit-risk assessment for the use of Eli Lilly’s donanemab for Alzheimer’s disease (AD). 7 June 2024
The recent approval by the US Food and Drug Administration (FDA) of Moderna’s (Nasdaq: MRNA) respiratory syncytial virus (RSV) vaccine mRESVIA represents a significant development in the field and will likely encourage the use of mRNA technology across other disciplines. 7 June 2024
The US Food and Drug Administration (FDA) late Thursday announced the approved of Geron Corporation’s Rytelo (imetelstat), an oligonucleotide telomerase inhibitor. 7 June 2024
Moderna has announced that the US Food and Drug Administration has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. 6 June 2024
A report from industry analyst GlobalData finds that reforms to the European Union's general pharmaceutical legislation have become a pivotal policy development for the pharma industry. 6 June 2024
Italy’s Philogen and Indian drugmaker Sun Pharmaceutical Industries have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun). 5 June 2024
Lykos Therapeutics’ hopes of being the first to market with a hallucinogenic medicine suffered a major blow Tuesday during a meeting of the US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC). 5 June 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 September 2024
The US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). 12 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 12 September 2024
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) will come under the microscope when the US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee meets on Friday. 12 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
The research based pharmaceutical industry has welcomed Mario Draghi’s report, published by the European Commission, outlining proposals on how Europe can regain its competitive edge and the critical role of innovative industries in achieving this. 11 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
The US House of Representatives has passed the BIOSECURE Act, gaining bipartisan support with a vote of 306–81. Nearly all of the votes against the bill came from Democrats. 10 September 2024
Cartesian Therapeutics today announced that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). 9 September 2024
The Innovative Health Initiative (IHI)—a European Union (EU) public-private partnership funding health research and innovation—has boasted that it has made a major step forward for animal welfare. 9 September 2024