The US Food and Drug Administration has issued a complete response letter (CRL) regarding the New Drug Application for CCP-07, a long-acting cough-cold formulation for UK-based Vernalis. 21 April 2017
Genentech, part of Swiss pharma giant Roche, has received accelerated approval from the US Food and Drug Administration (FDA) for its cancer immunotherapy Tecentriq (atezolizumab) to treat people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. 19 April 2017
Indian generic drugmaker Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration for anti-depressive medication vilazodone hydrochloride. 19 April 2017
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. 18 April 2017
The US Food and Drug Administration has approved Lucentis (ranibizumab injection) for the monthly treatment of all forms of diabetic retinopathy, reported Genentech, a subsidiary of Swiss pharma giant Roche, which markets the drug in the USA. 18 April 2017
In a holiday-shortened week, there were still a bunch of important announcements, among which was the US approval of Neurocrine Sciences’ movement disorder drug Ingrezza, two lots of bad news for OncoMed and Bristol-Myers Squibb offloaded two product candidates as well as entering a research collaboration with Apexigen. 17 April 2017
The US Food and Drug Administration has issued a complete response letter for the New Drug Application (NDA) of the investigational medicine baricitinib, a once-daily oral JAK inhibitor for the treatment of moderate-to-severe rheumatoid arthritis (RA). 17 April 2017
Israel’s Teva Pharmaceutical Industries revealed in a filing with the US Securities and Exchange Commission that, on April 10, it received a Warning Letter from the US Food and Drug Administration. 14 April 2017
A new analysis comparing the performance of the US Food and Drug Administration and the European Medicines Agency has found that the FDA approves drugs three to four months faster than its European counterpart. 13 April 2017
The US Food and Drug Administration (FDA) has warned Netherlands incorporated Mylan that unless it addresses manufacturing violations at its facility in Maharashtra, India, then the agency could withhold approval of any new applications or supplements listing the firm as a drug manufacturer. 12 April 2017
The US Food and Drug Administration has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). 12 April 2017
The US Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of September 8, 2017 for its decision on the New Drug Application for Zerviate (cetirizine ophthalmic solution) 0.24%. 11 April 2017
US Representatives David McKinley (Republican: West Virginia-1) and Peter Welch (Democrat: Vermont) last week introduced the Fair Access for Safe and Timely (FAST) Generics Act. 8 April 2017
Shares in US pharma giant Merck & Co slipped in the morning’s trading on news that the US Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the company’s Supplemental New Drug Applications for Januvia (sitagliptin) and its two Janumet (sitagliptin and metformin HCl) formulations. 7 April 2017
The US Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. 7 April 2017
The US Food and Drug Administration has granted Breakthrough Therapy designation status to evinacumab for the treatment of hypercholesterolemia in patients with homozygous familial hypercholesterolemia (HoFH). 6 April 2017
The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) to extend the use of Opdivo (nivolumab). 5 April 2017
Amgen has filed a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for Xgeva (denosumab). 4 April 2017
The US Food and Drug Administration has approved Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease, Teva Pharmaceutical has announced. 4 April 2017
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
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
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 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
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
Cartesian Therapeutics today announced that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). 9 September 2024
ProKidney announced strategic updates to its Phase III program for rilparencel, an investigational treatment to potentially preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease (CKD). 9 September 2024
Last week’s research news included French pharma major Sanofi releasing mixed Phase III results for it tolebrutinib in progressive multiple sclerosis. Also of note, US vaccine developer Vaxcyte announced strong early-stage trial results for its VAX-31 in pneumococcal disease. On the regulatory front, US drugmaker Travere Therapeutics gained full approval from the US Food and Drug Administration (FDA) for its kidney disease drug Filspari. US cancer drug developer IN8bio announced a prioritization of its R&D pipeline to focus on INB-100 in acute myeloid leukemia, along with a workforce cutback. 8 September 2024