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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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 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 accepted Biologics License Applications (BLAs) from Swiss pharma giant Roche and Belgium’s UCB, and granted them accelerated review. 6 January 2023
It has been a long road for Geron’s telomerase blocker, but the company is now finally planning a commercial launch for imetelstat in 2024. 5 January 2023
UK pharma major AstraZeneca said today that its Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants. 5 January 2023
In November 2022, the US Food and Drug Administration (FDA) hosted a webinar on the topic Understanding Generic Narrow Therapeutic Index (NTI) Drugs. The aim of the webinar was to educate healthcare professionals on NTI drugs and the FDA’s efforts to ensure therapeutic equivalence of generic NTI drugs.1 3 January 2023
South Korea’s Samsung Bioepis says that Health Canada has approved its Hadlima (also known as SB5) - a citrate-free, high concentration (40mg/0.4 ML) formulation of biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 3 January 2023
USA-based Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel). 3 January 2023
A marketing authorization submission for talquetamab - an immunotherapy with the potential to shake up the multiple myeloma market - is now sat on regulators’ desks at the European Medicines Agency. 3 January 2023
The Food and Drug Administration (FDA) has now approved TG Therapeutics’ Briumvi (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 31 December 2022
Faith in the transparency of the US regulatory process has been shaken, following an accusatory report from influential congressional committees into the approval of Aduhelm (aducanumab). 30 December 2022
AstraZeneca’s Calquence (acalabrutinib) has secured a new approval in Japan, for the treatment of adults with chronic lymphocytic leukemia (CLL), in the first-line setting. 28 December 2022
The US Food and Drug Administration (FDA) has approved Olpruva (sodium phenylbutyrate; ACER-001) for oral suspension for the treatment of certain patients living with urea cycle disorders (UCDs). 28 December 2022
South Korea’s Celltrion Healthcare has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for its lead product candidate, CT-P13 SC (also known as Remsima), which is the subcutaneous formulation of infliximab, to the US Food and Drug Administration (FDA). 28 December 2022
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab [genetical recombination]) intravenous infusion for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma). 27 December 2022
Following marketing authorization by the European Commission in August for the same indication, the US Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. 23 December 2022
Ahead of the expected December 29 action date, and adding to European approval in June, the US Food and Drug Administration (FDA) yesterday granted marketing authorization for Swiss pharma giant Roche subsidiary Genentech’s Lunsumio (mosunetuzumab-axgb). 23 December 2022
Following a previous rejection by the agency, the US Food and Drug Administration (FDA) has now accepted for review the Biologics License Application (BLA) resubmission for bimekizumab, filed by Belgium’s largest drugmaker UCB, for the treatment of adults with moderate to severe plaque psoriasis. 23 December 2022
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, which was developed by Kite pharma, now a subsidiary of US biotech Gilead Sciences. 23 December 2022
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022
Roche company Genentech has won US approval for its intravenous Actemra (tocilizumab) product, for adults that have been hospitalized with COVID-19. 22 December 2022