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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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 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 life sciences industry has always been subjected to transparency requirements. To help avoid compliance violations that may lead to penalties, many life science organizations have ramped up their efforts to collect compliance data and streamline the reporting process. 10 May 2023
Effective June 1, 2023, prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists, in Australia. 10 May 2023
The poor execution of a Phase III trial in Lyme disease has set back plans to submit vaccine candidate VLA15 for regulatory approval in the USA. 5 May 2023
A number of top Indian drugmakers have requested that the Drug Controller General of India gives pharmaceutical companies a 'fair chance' to review the quality of drug samples that have been declared 'not of standard quality' (NSQ) before publishing any drug alert. 4 May 2023
The European Medicines Agency is considering changing the transparency rules around clinical trials, with a public consultation on the matter now open. 4 May 2023
The US Food and Drug Administration has approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the USA, achieving. an elusive quest that has been decades in the making. 4 May 2023
The European Commission (EC) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for a number of new lymphoma indications. 3 May 2023
Indian drug major Sun Pharma Industries dipped just 1% to 962.60 rupees, despite the company announcing a setback in the development of its newly-acquired product candidate deuruxolitinib. 3 May 2023
Health Canada has granted marketing authorization for Quviviq (daridorexant) for the management of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. 3 May 2023
The US Food and Drug Administration announced yesterday it is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. 3 May 2023
The Franco-Israeli partnership of MedinCell and Teva Pharmaceutical Industries has announced today that the US Food and Drug Administration (FDA) has approved Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. 2 May 2023
Shares of Danish biotech Ascendis Pharma leapt, despite the company revealing that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the TransCon PTH (palopegteriparatide) New Drug Application (NDA) for the treatment of adults with hypoparathyroidism. 2 May 2023
A 12% jump in the stock price of Avadel Pharmaceuticals on Monday reflects market confidence in the firm’s newly-approved cataplexy med Lumryz (sodium oxybate). 2 May 2023
Australian medicines regulator the Therapeutic Goods Administration (TGA) has approved the application from the local subsidiary of US mRNA vaccines specialist Moderna to transition its COVID-19 vaccine, Spikevax (elasomeran), from provisional to full registration. 28 April 2023
The European medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its April 2023 meeting. 28 April 2023
When it comes to getting a novel foreign-made treatment into China as quickly as possible, companies should also look into the local policies in some high-profile special zones. 27 April 2023