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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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 research based pharmaceutical industry has welcomed Mario Draghi’s report, published by the European Commission, outlining proposals on how Europe can regain its competitive edge and the critical role of innovative industries in achieving this. 11 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
The US House of Representatives has passed the BIOSECURE Act, gaining bipartisan support with a vote of 306–81. Nearly all of the votes against the bill came from Democrats. 10 September 2024
The US Food and Drug Administration (FDA) yesterday issued a Complete Response Letter (CRL) regarding US drug developer Galera Therapeutics New Drug Application (NDA) for avasopasem manganese for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment. 10 August 2023
First granted US accelerated approval in 2020, the Food and Drug Administration on Wednesday converted this to regular approval of Gavreto (pralsetinib) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. 10 August 2023
The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted unanimously by 10 to 0 to recommend routine use of Beyfortus (nirsevimab-alip). 7 August 2023
The US Food and Drug Administration (FDA) approved Japanese drug major Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) late Friday, 7 August 2023
Friday produced a mixed decision from the US Food and Drug Administration (FDA) for biotechs Sage Therapeutics and its partner Biogen regarding their new type of antidepressant. 5 August 2023
Australian regenerative medicine company Mesoblast saw its shares plunge almost 57% to A$0.47 after it revealed a second setback in the development of it remestemcel-L. 4 August 2023
The US Food and Drug Administration (FDA) has approved Lonsurf (trifluridine/tipiracil), developed by Taiho Oncology Inc and Taiho Pharmaceutical, subsidiaries of Japanese drugmaker Otsuka Holdings, with the decision coming ahead of the August 13 expected date. 3 August 2023
Japanese companies have been slow to progress COVID-19 vaccines, but today Daiichi Sankyo announced that it has received approval for the manufacturing and marketing of Daichirona for Intramuscular Injection (DS-5670). 2 August 2023
Bimervax, the COVID-19 vaccine developed by Spanish company HIPRA Human Health, has today been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 1 August 2023
The US Food and Drug Administration approved UK pharma major GSK’s Jemperli (dostarlimab-gxly)) with carboplatin and paclitaxel for primary advanced or recurrent endometrial cancer. 1 August 2023
Building up on its sizeable global presence in the oncology space, Venus Remedies, an India-based provider of affordable cancer drugs worldwide, has extended its reach with marketing approvals for key cancer drugs from Philippines, Paraguay, Georgia and Moldova. 31 July 2023
The US Food and Drug Administration has dealt a blow to the market value of New Jersey, USA-based oncology company Citius Pharmaceuticals. 31 July 2023
AstraZeneca has reported total revenues of $11.4 billion in the second quarter of 2023, a rise of around 6%, beating expectations from most analysts. 28 July 2023
Belgium’s largest pharma company UCB has posted a downbeat set of financials for the first half of 2023, with revenues falling 11% to 2.6 billion euros ($2.9 billion). 27 July 2023
UK pharma major AstraZeneca this morning revealed that Soliris (eculizumab) has been approved in the European Union (EU) for expanded use. 27 July 2023
The US Food and Drug Administration (FDA) yesterday approved Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. 26 July 2023
The US Food and Drug Administration (FDA) has granted approval of Balfaxar (prothrombin complex concentrate, human-lans) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. 26 July 2023
Shares in Stoke Therapeutics have fallen by a third after the company announced what it described as “positive new safety and efficacy data” from its early stage trial program for STK-001. 26 July 2023
In a change of stance from its earlier proposal, India's Health Ministry has proposed that either the state or central authorities be empowered to regulate drugs and cosmetic manufacture, instead of only the Central Drugs Standard Control Organization (CDSCO). 26 July 2023
The SGLT2 inhibitor drug Jardiance (empagliflozin), developed and marketed by family-owned German pharma major Boehringer Ingelheim and the USA’s Eli Lilly, has won approval from the European Commission for the new indication of chronic kidney disease (CKD). 25 July 2023