Ireland-incorporated Jazz Pharmaceuticals today revealed it has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. 22 January 2020
On Tuesday, the US Food and Drug Administration approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease (TED), a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). 22 January 2020
The US Food and Drug Administration has granted Priority Review status to a submission from British drugmaker GlaxoSmithKlinefor belantamab mafodotin. 21 January 2020
Indian drugmaker Strides Pharma Science says its step-down subsidiary, Strides Pharma (SPI), has received a positive Establishment Inspection Report (EIR) from the US Food and Drug Administration for its facility in Riviera Beach, Florida, USA. 21 January 2020
Danish cancer specialist Genmab has been awarded marketing authorization in the EU for a combination therapy of Darzalex (daratumumab) plus bortezomib, thalidomide and dexamethasone. 21 January 2020
Swiss pharma giant Roche today announced that the European Commission has granted conditional marketing authorization for Polivy (polatuzumab vedotin), in combination with bendamustine plus MabThera (rituximab) (BR). 21 January 2020
In a second new drug approval on Monday, the European Commission cleared Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). 21 January 2020
The European Commission (EC) has approved Mayzent (siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. 20 January 2020
A new report has been published by the joint Big Data Task Force of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). 20 January 2020
A US Food and Drug Administration (FDA) advisory panel vote on whether to approve Durect Corporation’s painkiller Posimir (bupivacaine) ended in a tie. 20 January 2020
A bid from Lynparza (olaparib) co-developers AstraZeneca and Merck & Co to broaden the label in the USA has been granted Priority Review status. 20 January 2020
At its January meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety. 17 January 2020
The US Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) have issued another negative vote on a opioid alternative pain drug within a matter of days. 17 January 2020
A coveted Rare Pediatric Disease (RPD) designation has been issued to Fortress Biotech’s partner for its investigational Menkes disease candidate CUTX-101. 17 January 2020
A list of approved biologics that are set to go from being regarded as New Drug Applications (NDAs) to Biologics License Applications (BLAs) has been updated. 16 January 2020
The evolution in the regulation of prescription medicines from the 1980s to 2018, and trends in drug approvals, come under the microscope in an analysis published in JAMA this week. 16 January 2020
The US Food and Drug Administration (FDA) has issued an alert over the results from a clinical trial showing a possible increased risk of cancer with the weight management drug Belviq/Belviq XR (lorcaserin). 15 January 2020
ViiV Healthcare says it has obtained approval of Dovato (dolutegravir 50mg/lamivudine 300mg) from the Japan Ministry of Health, Labor and Welfare. 15 January 2020
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