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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
At its March 23-26 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its March 2020 meeting. 27 March 2020
Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza (baloxavir marboxil). 27 March 2020
Switzerland-based CNS disorders specialist Arvelle Therapeutics today announced that the European Medicines Agency has accepted the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy. 27 March 2020
Bristol-Myers Squibb has received US approval for Zeposia (ozanimod) for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 26 March 2020
Italian drugmaker Recordati today announced the submission of the Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for osilodrostat, an oral inhibitor of 11-beta-hydroxylase for the treatment of patients with Cushing’s syndrome (CS). 26 March 2020
The US Food and Drug Administration has accepted for filing with Priority Review the New Drug Application (NDA) seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness (EDA) in patients seven years of age and older with narcolepsy. 26 March 2020
US biotech Gilead Sciences said on Wednesday that it has submitted a request to the US Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits that accompany the designation. 26 March 2020
Ipsen shares began trading around 2% higher on Thursday morning, after the French biotech announced today it would restart the global Phase III MOVE trial, in people over the age of 14. 26 March 2020
Sino-America immuno-oncology biotech firm BeiGene today announced that, on March 25, 2020, the China National Medical Products Administration (NMPA) suspended the importation, sales and use of Abraxane (nanoparticle albumin-bound paclitaxel) in China supplied to BeiGene by Celgene, now a Bristol-Myers Squibb company. 25 March 2020
Ono Pharmaceutical has received manufacturing and marketing approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of recurrent or refractory primary central nervous system lymphoma, in Japan. 25 March 2020
Germany’s Merck KGaA has won Japanese approval for Tepmetko (tepotinib), for the treatment of certain people with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC). 25 March 2020
As the world watches aghast, the novel coronavirus continues to spread its tentacles around the globe, with cases of COVID-19 rising to nearly 375,000 on Tuesday, an increase of 75,000 from the day before. 25 March 2020
The US Food and Drug Administration (FDA) has issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during what it calls the ‘public health emergency’ of the COVID-19 crisis. 23 March 2020
Japanese pharma major Takeda Pharmaceutical has picked up an approval in China for Entyvio (vedolizumab), for moderate to severe active ulcerative colitis (UC) or Crohn's disease (CD). 23 March 2020
The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental New Drug Application (sNDA) of the investigational drug empagliflozin 2.5mg as an adjunct to insulin for adults with type 1 diabetes. 23 March 2020