On Wednesday, the American Heart Association (AHA)/American College of Cardiology (ACC) Joint Committee on Clinical Practice Guidelines issued a new clinical guideline for the evaluation and management of people with hypertrophic cardiomyopathy (HCM). 9 May 2024
2023 marked a significant upsurge in US Food and Drug Administration (FDA) approvals, particularly for ground-breaking treatments such as cell and gene therapies. 9 May 2024
The US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) will review data supporting the new drug application (NDA) submitted by Lykos Therapeutics for midomafetamine (MDMA) capsules. 8 May 2024
Swedish Orphan Biovitrum has announced that the European Commission (EC) has approved an indication extension for Aspaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who have hemolytic anemia. 8 May 2024
The top management of life sciences companies is very optimistic about 2024 and 2025, with over 80% of pharmaceutical, medical technology and biotechnology executives expecting profit growth for the current year and over 90% for the coming year. 8 May 2024
The US Food and Drug Administration (FDA) has now said it will convene an in person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on June 10, 2024, to discuss the Alzheimer's drug donanemab. 8 May 2024
The first drug for the treatment of ankylosing spondylitis has been registered in the Russian Federation, according to the country’s Ministry of Health and local media reports. 7 May 2024
The Bilateral III, a third package of bilateral agreements between the European Union (EU) and Switzerland on participation in the Single Market, ensures unhindered access to the European internal market and puts the economic and political relationship with the EU on a solid foundation, says the Swiss trade group InterPharma. 7 May 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved two new formulations of the medicine cabotegravir to help prevent sexually transmitted HIV-1 infection. 3 May 2024
X4 Pharmaceuticals has secured US approval for Xolremdi (mavorixafor), for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis). 30 April 2024
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign. 30 April 2024
On April 29, the US Food and Drug Administration granted traditional approval to Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 30 April 2024
More prominent warnings are to be added to the package insert of montelukast (Singulair) in the UK, reminding patients and healthcare professionals that they should be alert to serious behavior and mood-related changes (neuropsychiatric reactions) associated with the treatment, said the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 30 April 2024
Interpharma, the association of research-based pharmaceutical companies in Switzerland, has called on lawmakers to reconsider a cost containment package which it says “is putting patient access at risk.” 29 April 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