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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
UK pharma major GSK’s shares closed down 6% at 1,323.60 pence on Friday, as it said that it would only recommend its ovarian-cancer treatment Zejula (niraparib) as a secondary maintenance treatment to a subgroup of patients in the US who carry a specific genetic mutation connected to breast cancer, known as BRCA. 14 November 2022
The European Commission (EC) has granted approval for the marketing authorization application for Livtencity (maribavir) that was submitted by Japan’s largest drugmaker Takeda. 14 November 2022
Following its November 2022 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four medicines for approval, one a biosimilar, two generics and the other a coronavirus vaccine. 11 November 2022
The European Commission has granted a marketing authorization for Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis, developed by Germany’s STADA Arzneimittel and Sweden’s Xbrane Biopharma. 11 November 2022
The US Food and Drug Administration has granted a new approval to a checkpoint inhibitor combo developed by AstraZeneca, Imfinzi (durvalumab) plus Imjudo (tremelimumab), in lung cancer. 11 November 2022
The US Food and Drug Administration (FDA) yesterday issued an emergency use authorization (EUA)for Kineret (anakinra) injection for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) 10 November 2022
The checkpoint blocker Libtayo (cemiplimab-rwlc) has secured US approval for the first-line treatment of certain adults with advanced non-small cell lung cancer (NSCLC). 9 November 2022
Hopes that the novel antibody-drug conjugate (ADC) camidanlumab tesirine (Cami) might soon secure a review under the Accelerated Approval scheme have been dashed. 9 November 2022
UK pharma major AstraZeneca today reported that the US Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee has voted overwhelmingly to recommend approval of PT027 (albuterol/budesonide) as a new rescue treatment in the USA for people 18 years of age and older, but was not so supportive for younger age groups. 9 November 2022
The US Food and Drug Administration (FDA) yesterday published a new draft guidance for industry, titled “Sameness Evaluations in an ANDA – Active Ingredients.” 9 November 2022
Blue Earth Therapeutics’ investigational therapeutic radiopharmaceutical, 177Lu-rhPSMA-10.2, has been awarded an Innovation Passport by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of metastatic castrate-resistant prostate cancer. 9 November 2022
Shares in Sensorion, a French biotech that specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, were trading 17% higher on Monday afternoon. 7 November 2022
The US Food and Drug Administration (FDA) on Friday updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. 5 November 2022
The European Commission (EC) has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. 4 November 2022
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofovir alafenamide) 25mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease. 2 November 2022
Long available in Europe under an emergency nod, AstraZeneca's COVID-19 vaccine, Vaxzevria, has finally been granted full approval in the region. 1 November 2022
Sino-American biotech BeiGene claims significant progress in its efforts to unlock global opportunities for its Brukinsa (zanubrutinib) with recent regulatory approvals in six Latin American countries. 31 October 2022
Japanese drugmaker Kyowa Kirin revealed on Friday that is has submitted a New Drug Application (NDA) for tenapanor hydrochloride (KHK7791) to the Japanese Ministry of Health, Labor and Welfare. 31 October 2022