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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
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
Glenmark Pharmaceuticals today revealed it has just received manufacturing and marketing approval from India’s drug regulator to launch the oral antiviral drug favipiravir, trade name FabiFlu, for the treatment of mild to moderate COVID-19 patients in India. 19 June 2020
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) in two follicular lymphoma (FL) indications. 19 June 2020
Innovent Biologics has announced that Byvasda (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by China’s National Medical Products Administration (NMPA) for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China. 19 June 2020
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 19 June 2020
The US Food and Drug Administration has approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones. 19 June 2020
The US subsidiary of Spain’s largest drugmaker Almirall today announced that the US Food and Drug Administration has approved an important update to the Seysara (sarecycline) label stating that P. acne strains displayed a low propensity for the development of resistance to sarecycline. 18 June 2020
The marketing authorization application (MAA) for Brukinsa (zanubrutinib) to treat Waldenström’s macroglobulinemia (WM) patients who have received at least one prior therapy or as first-line treatment for those unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA). 18 June 2020
Hot on the heels of US regulatory clearance, Health Canada has also approved Kynmobi (apomorphine HCl) soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD), says Sunovion. 18 June 2020
The major European pharma trade groups have written to the European Commission president Ursula von der Leyen and other officials, to prioritize health and patients’ access to medicines in the EU-UK Brexit negotiations, and shield them from larger political considerations. 18 June 2020
Following recent results on the potential of dexamethasone in COVID-19, Seattle’s AVM Biotechnology has announced plans to launch its formulation of the drug for affected people. 18 June 2020
A review of clinical trial data suggests that increasing numbers of COVID-19 hydroxychloroquine studies will be nixed in the coming months. 18 June 2020
TG Therapeutics has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration requesting accelerated approval for umbralisib as a treatment for patients with previously-treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). 18 June 2020
The US Food and Drug Administration granted accelerated approval for an additional indication for Keytruda (pembrolizumab), Merck & Co’s best-selling drug with 2019 sales of $11.08 billion, and already approved for a number of cancer indications. 17 June 2020
Cosentyx (secukinumab), the only fully-human biologic directly targeting IL-17A, has picked up a new approval for a fourth indication in the USA. 17 June 2020
The first ever therapy for active and adult-onset Still’s disease (AOSD) has been approved in the USA, providing hope for people with the rare autoinflammatory condition. 17 June 2020
London-listed biotech firm PureTech Health’s founded entity, Akili Interactive, has gained US Food and Drug Administration clearance for EndeavorRx (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). 16 June 2020
The International Coalition of Medicines Regulatory Authorities (ICMRA) held its regular virtual meeting of global regulators last week to discuss high-level policy issues and regulatory approaches to ensure a coordinated response to the COVID-19 pandemic. 16 June 2020
The US Food and Drug Administration has approved Lyumjev (insulin lispro-aabc) injection, 100 units/mL and 200 units/mL, a new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. 16 June 2020
The US Food and Drug Administration (FDA) has approved Zepzelca (lurbinectedin) to treat metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. 16 June 2020
On Monday, the US Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. 16 June 2020