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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
US biotech major Gilead Sciences yesterday announced the US Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). 17 May 2022
The Serum Institute of India (SII) has sought the government’s approval to manufacture its indigenously developed quadrivalent human papillomavirus (qHPV) vaccine against cervical cancer, after the completion of Phase II/III clinical trials in order to ensure its early availability in the country. 16 May 2022
Shares of Travere Therapeutics were up 13% at $25.08 in early trading today, as it revealed that the US Food and Drug Administration has accepted and granted Priority Review of its New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN). 16 May 2022
Through its Institute of Drug Technology (Farmanguinhos/Fiocruz), Brazil’s Fiocruz signed has an agreement on technological cooperation with American pharmaceutical company MSD. 16 May 2022
On Friday, the US Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. 14 May 2022
Swedish rare disease specialist Hansa Biopharma today revealed that the Swiss Agency for Therapeutic Products (Swissmedic) has granted time-limited market approval for Idefirix (imlifidase) for adult patients with a positive cross-match against an accessible organ from a deceased donor. 13 May 2022
USA-based JSR Life Sciences has launched a new business division, Similis Bio (Similis), which will operate a partnering program designed to help biopharmaceutical companies improve the efficiency and cost of biosimilar development. 13 May 2022
The US Food and Drug Administration has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS). 13 May 2022
Innovation is critical to complete the green and digital transitions and to secure the EU’s open strategic autonomy. This is why a future-proof regulatory framework, which removes barriers to innovation, will allow cutting edge technology products to be developed and launched in Europe. 12 May 2022
Shares in Miami-based Veru were 4% higher at lunchtime Wednesday on the back of some good news from the US Food and Drug Administration (FDA). 11 May 2022
Japanese ophthalmology specialist Santen Pharmaceutical has received approval of Verkazia (ciclosporin eye drops) from the National Medical Products Administration (NMPA) in China through its Chinese legal entity for the treatment of severe vernal keratoconjunctivitis (VKC) in children and adolescents aged 4 years and above. 11 May 2022
The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has announced the launch of the new Accelerating Rare disease Cures (ARC) Program. 11 May 2022
The US Food and Drug Administration yesterday approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 11 May 2022
Alzheimer’s drug developer Eisai has completed a rolling submission to the US Food and Drug Administration for its next-gen anti-amyloid beta candidate lecanemab. 10 May 2022
The US Food and Drug Administration yesterday announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. 10 May 2022
Australia regulator the Therapeutic Goods Administration (TGA) has granted provisional approval for Gilead Sciences to extend the use of its COVID-19 treatment, Veklury (remdesivir). 9 May 2022
Swiss pharma giant Novartis announced that the European Commission (EC) has approved Jakavi (ruxolitinib) in acute or chronic graft-versus-host disease (GvHD) who have inadequate response to corticosteroids or other systemic therapies. 9 May 2022
Myovant Sciences and Pfizer on Friday announced today that the US Food and Drug Administration has extended the review period for the supplemental New Drug Application (sNDA) for Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) for the management of moderate to severe pain associated with endometriosis. 9 May 2022
The year 2021 was important for the development of new gene-, cell- and tissue-based therapies, and the Alliance for Regenerative Medicines (ARM) says this year will be another year of growth and progress for these advanced therapies, according to its 2021 annual report. 9 May 2022