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Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024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
Just a month after winning its first US approval for sickle cell disease (SCD), Casgevy (exagamglogene autotemcel [exa-cel]) has won a second Food and Drug Administration (FDA) approval. 17 January 2024
After first approving the drug in 2014 for the treatment of primary immunodeficiency (PI) in adults, the US Food and Drug Administration (FDA) has now approved a new indication for HyQvia [immune globulin Infusion 10% (Human) with recombinant human hyaluronidase]. 17 January 2024
The European Commission has granted marketing authorization for yet another indication for Swiss pharma giant Roche’s cancer drug Tecentriq SC (atezolizumab; subcutaneous). 16 January 2024
Switzerland’s medicines regulator, Swissmedic, has updated its guidance regarding the authorization of generic medicines with certain active pharmaceutical ingredients (API). 16 January 2024
The Indian government has urged the United States to enhance the frequency of inspections carried out by the US Food and Drug Administration (FDA) in India, aiming to boost pharmaceutical exports. 16 January 2024
French healthcare non-profit Médecins Sans Frontières (MSF) has called on European lawmakers to amend a proposed law which would result in an effective export ban. 16 January 2024
The European Medicines Agency (EMA) has adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in preschool children (3 months to 6 years old), the Brazilian research organization Fiocruz has announced. 15 January 2024
The International Society for Cell and Gene Therapy (ISCT) has announced the publication in Nature Medicine of a commentary addressing a statement from the US Food and Drug Administration (FDA) that it is investigating serious risk of T-cell malignancy in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapy. 12 January 2024
A generics drugmaker has had its Abbreviated New Drug Application for the radiopharmaceutical 177Lu-PNT2003 accepted by the US Food and Drug Administration. 12 January 2024
Swiss specialty pharma Santhera Pharmaceuticals has announced that Agamree (vamorolone) has been approved in the UK for Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status. 12 January 2024
The US Food and Drug Administration (FDA) has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 (GLP-1) receptor agonists. 12 January 2024
The New Drug Application (NDA) for China-based Hutchmed’s sovleplenib as a treatment of adult patients with primary immune thrombocytopenia (ITP) has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA). 11 January 2024
The European Commission (EC) has granted conditional marketing authorization for Krazati (adagrasib), from US biotech Mirati Therapeutics. 11 January 2024
Japanese drugmaker Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of its Alzheimer’s disease drug Leqembi (lecanemab) which is currently under review by the European Medicines Agency (EMA). 11 January 2024
China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. 10 January 2024
China-based Innovent Biologics has announced that the first Phase III clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with overweight or obesity (GLORY-1) met the primary endpoints and all key secondary endpoints. 10 January 2024