Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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 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
Privately-held neurology company Tris Pharma has received approval from the US Food and Drug Administration for Onyda XR (clonidine hydrochloride). 3 June 2024
Biotech firm Moderna has won US Food and Drug Administration (FDA) approval for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. 31 May 2024
The US Food and Drug Administration yesterday approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL). 31 May 2024
The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). 31 May 2024
Biogen has announced European approval for Qalsody (tofersen), for certain amyotrophic lateral sclerosis (ALS) patients, under exceptional circumstances. 31 May 2024
Danish allergy immunotherapy specialist ALK Abell today revealed that its European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities. 30 May 2024
The US Food and Drug Administration granted accelerated approval to Retevmo (selpercatinib) from US pharma major Eli Lilly for pediatric patients two years of age and older. 30 May 2024
The US Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) submitted by Jazz Pharmaceuticals for zanidatamab, the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody. 30 May 2024
The US Food and Drug Administration (FDA) has accepted the New Drug Application and granted Priority Review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance) and fulvestrant, under development by Swiss pharma giant Roche. 29 May 2024
US biotech Insmed (Nasdaq: INSM) yesterday released positive top-line results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase III trial to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. 29 May 2024
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sarclisa (isatuximab) alongside bortezomib, lenalidomide and dexamethasone (VRd) for transplant-ineligible newly diagnosed multiple myeloma (NDMM). 28 May 2024