Novo Nordisk has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration and a Type II Variation application to the European Medicines Agency. 26 October 2016
The US Food and Drug Administration has granted earlier-than-expected approval for Merck & Co’s Keytruda (pembrolizumab) for use in previously untreated lung cancer patients, making it the only such drug so far cleared for first-line treatment. 25 October 2016
Beximco Pharmaceuticals has received US Food and Drug Administration approval for sotalol hydrochloride, a generic version of the cardiovascular drug Betapace. 25 October 2016
Inovio Pharmaceuticals saw its shares tank, after it announced that the US Food and Drug Administration has placed a clinical hold on its proposed Phase III clinical program for VGX-3100. 24 October 2016
Melinta Therapeutics has submitted New Drug Applications (NDAs) to the US Food and Drug Administration for approval of IV and oral Baxdela (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). 24 October 2016
GlaxoSmithKline has filed a Biologics License Application (BLA) to the US Food and Drug Administration for its shingles vaccine Shingrix. 24 October 2016
The US Food and Drug Administration on Friday approved pharma giant Merck & Co’s Biologics Licensing Application for Zinplava (bezlotoxumab) Injection 25mg/mL. 22 October 2016
The US Food and Drug Administration approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. 22 October 2016
The US Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). 21 October 2016
The US Food and Drug Administration has granted accelerated approval for pharma major Eli Lilly’s Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons or other soft tissues. 20 October 2016
Roche’s subsidiary Genentech has received approval for the US Food and Drug Administration for Tecentriq (atezolizumab) for the treatment of certain people with metastatic non-small cell lung cancer (NSCLC). 19 October 2016
AstraZeneca today announced that the US Food and Drug Administration has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9). 18 October 2016
The US Food and Drug Administration and representatives from the generic drug industry have reached an agreement in principle on proposed recommendations for the first reauthorization of the generic drug user fee program. 15 October 2016
The US Food and Drug Administration has advised specialty drugmaker Egalet that it will not meet the previously announced October 14 prescription drug user fee act (PDUFA) date for the company’s Arymo ER (morphine sulfate). 14 October 2016
The US Food and Drug Administration has accepted for review the New Drug Application (NDA) from Sunovion Pharmaceuticals for SUN-101 (glycopyrrolate). 14 October 2016
The US Food and Drug Administration has approved privately-held US biotech Protein Sciences’ quadrivalent formulation of Flublok influenza vaccine, which protects against four strains of influenza, three of the same strains found in trivalent Flublok plus an additional B strain. 12 October 2016
NicOx has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the New Drug Application (NDA) for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis. 10 October 2016
Danish diabetes care giant Novo Nordisk revealed on Friday that it has received a Complete Response Letter from the US Food and Drug Administration regarding the New Drug Application for faster-acting insulin aspart. 8 October 2016
The US Food and Drug Administration has approved Danish CNS specialist Lundbeck’s Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. 8 October 2016
The US Food and Drug Administration is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. 5 October 2016
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