The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
Sponsors of clinical trials run in the European Union have been reminded of their obligation to publish summaries of results in the EU Clinical Trials Database (EudraCT). 3 July 2019
US biotech Gilead Sciences and Belgium-based partner Galapagos both saw their shares go up by close of trading yesterday, after Gilead provided an update about the investigational oral, selective JAK1 inhibitor, filgotinib. 3 July 2019
The European Commission’s approval of Dovato (dolutegravir/lamivudine) has been hailed as an important milestone for HIV patients because this therapy offers a different option to three-drug regimens. 3 July 2019
In a business update, cardiovascular specialist Amarin said the market opportunity for its heart med Vascepa (icosapent ethyl) is larger than previously thought. 3 July 2019
The European Medicines Agency (EMA) is seeking to ensure that its regulatory processes keep pace with the innovation and change going on in the drug development industry. 2 July 2019
The US Food and Drug Administration has issued new draft guidance providing recommendations for drugmakers on how to create an Instructions for Use (IFU) document. 2 July 2019
National Health Service patients in the UK will be the first to gain access in Europe to new skin cancer treatment, Libtayo (cemiplimab), through the Cancer Drugs Fund (CDF), it was revealed today, just a day after the drug won conditional regulatory approval from the European Commission. 2 July 2019
Libtayo (cemiplimab) has been granted conditional approval for the treatment of certain adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), one of the most commonly diagnosed skin cancers worldwide. 1 July 2019
Close on the heels of an alert raised by the US Food and Drug Administration and Health Canada regarding the safety of sodium glucose cotransporter-2 (SGLT-2) inhibitors from Johnson & Johnson (NUSE: JNJ) and Germany-based Boehringer Ingelheim, the Drug Controller General of India (DCGI) has asked drug manufacturers to carry a warning label on all new diabetes drugs, reports The Pharma Letter’s India correspondent. 1 July 2019
The new biotechnology report describing the situation of medical biotechnology in Germany is now available on the website of the German trade group the VFA. 1 July 2019
Gross domestic product (GDP) in Japan is about $5 trillion, and the country’s pharmaceutical market is one of the largest in the world, with figures from the Ministry of Health, Labour and Welfare (MHLW) indicating a market value of about $95 billion, including non-prescription medications. 28 June 2019
Another biosimilar of one of the world’s best-selling oncology drugs, Avastin (bevacizumab), has been approved by the US Food and Drug Administration (FDA). 28 June 2019
Privately-held Danish vaccines specialist AJ Vaccines has won approval in Denmark for its adjuvanted IPV vaccine, after positive results from clinical trials involving almost 3,000 infants. 28 June 2019
Danish drugmaker Genmab has won US approval for Darzalex (daratumumab), in combination with lenalidomide and dexamethasone (Rd) to treat people with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). 28 June 2019
At its June meeting, the European Medicines Agency’ Committee for Medicinal Products for Human Use (CHMP) issued recommendations on three medicines for approval, plus a negative opinion and some indications extensions. 28 June 2019
The US Food and Drug Administration yesterday approved the first biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), and thus marking a third approved indication for Dupixent (dupilumab). 27 June 2019
US biopharma Titan Pharmaceuticals has clocked up a third major market approval for an opioid dependence substitutional treatment that it developed. 27 June 2019