The US Food and Drug Administration yesterday revealed it has granted traditional approval for Tepmetko (tepotinib,) from EMD Serono, a US subsidiary of Germany’s Merck KGaA. 16 February 2024
The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. 16 February 2024
US biopharma Citius Pharmaceuticals has announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Lymphir (denileukin diftitox) for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. 15 February 2024
Today, the US Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. 14 February 2024
The US Food and Drug Administration (FDA) has extended the Priority Review period for the Biologics License Application (BLA) for Kresladi (marnetegragene autotemcel; formerly RP-L201) for severe leukocyte adhesion deficiency-I (LAD-I). 14 February 2024
The US Food and Drug Administration (FDA) has approved Onivyde (irinotecan liposome), from French drugmaker, in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX regime), for the first-line treatment of metastatic pancreatic adenocarcinoma (mPDAC). 14 February 2024
Japanese pharma major Takeda has announced that the US Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). 13 February 2024
Genetic disease company Vertex Pharmaceuticals has secured conditional marketing authorization for Casgevy (exagamglogene autotemcel) in Europe. 13 February 2024
The European Commission (EC) has authorized Biogen’s Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. 13 February 2024
On Friday, the US Food and Drug Administration (FDA) issued a final rule to amend its regulations concerning the use of master files for biological products. 12 February 2024
Following an inspection from the US medicines regulator, a manufacturing site run by Indian active pharmaceutical ingredient (API) specialist Aparna Pharmaceuticals has received a VAI classification. 12 February 2024
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with the COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir). 9 February 2024
Crovalimab, a humanized complement inhibitor C5 monoclonal antibody discovered by Japan’s Chugai Pharmaceutical (TYO: 4519), has been approved by China’s National Medical Products Administration (NMPA) for treatment of PNH. 8 February 2024
Hong Kong-listed biotech BeiGene has received Health Canada authorization for Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory grade 1, 2 or 3a follicular lymphoma (FL). 8 February 2024
The UK's Medicines and Healthcare Regulatory Agency (MHRA) has licensed subcutaneous (SC) injectable Vyvgart (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. 7 February 2024
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics’ made history by gaining the first FDA approval for a CRISPR-based drug, Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease with vaso-occlusive crisis. 6 February 2024
UK pharma major GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) is currently undergoing regulatory review with the potential of being approved in Europe for use in adults aged between 50 and 59 who are at an increased risk for respiratory syncytial virus (RSV) infection. 5 February 2024
Adaptimmune Therapeutics saw its shares leap almost 10% by close of trading Wednesday and a further 5.2% to $1.01 in after-hours trading as it announced a regulator development for its cell therapy. 1 February 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
The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent. 12 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
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Sanofi’s mega blockbuster drug Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. 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
The research based pharmaceutical industry has welcomed Mario Draghi’s report, published by the European Commission, outlining proposals on how Europe can regain its competitive edge and the critical role of innovative industries in achieving this. 11 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
The US House of Representatives has passed the BIOSECURE Act, gaining bipartisan support with a vote of 306–81. Nearly all of the votes against the bill came from Democrats. 10 September 2024