The European Commission (EC) has granted marketing authorization for the interleukin (IL)-17A and IL-17F inhibitor Bimzelx (bimekizumab), from Belgian drugmaker UCB's, for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 22 April 2024
The European Commission (EC) has granted marketing authorization for Pyzchiva (biosimilar ustekinumab), said Swiss generics and biosimilars company Sandoz. 22 April 2024
The European Federation of pharmaceutical Industries Associations (EFPIA) and its members support the European Union (EU) leaders call for a new European Competitiveness Deal and call for a dedicated Health and Life Sciences Strategy as part of the wider strategy. 22 April 2024
The US Food and Drug Administration (FDA) has posted a safety communication to inform the public and healthcare providers that the agency has required and approved labeling changes to the US Prescribing Information (USPI) for all licensed BCMA-directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies. 20 April 2024
Japanese pharma giant Takeda has picked up a new approval for subcutaneous Entyvio (vedolizumab), for maintenance therapy of severely active Crohn’s disease. 19 April 2024
The US Food and Drug Administration (FDA) has approved the first and only ALK inhibitor for people with ALK-positive early-stage NSCLC (eNSCLC). 19 April 2024
American biopharma companies have criticised new European pharmaceutical legislation designed to make medicines more available, accessible and affordable. 18 April 2024
US biotech Vertex Pharmaceuticals’ shares gained ground in early trading today after the company signaled progress in the development of its experimental non-opioid pain treatment. 18 April 2024
A division of Medicines for Europe, the trade group representing the region's generics and biosimilars firms, has called for a new strategy to promote the biosimilars sector. 18 April 2024
The Icelandic-Israeli pairing of Alvotech and Teva Pharmaceutical Industries have announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use. 17 April 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Fintepla (fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. 17 April 2024
The Phase I trial of NMRA-266 has been placed on clinical hold by the US Food and Drug Administration (FDA), said the drug’s developer, Massachusetts, USA-based based brain disease biotech Neumora Therapeutics. 15 April 2024
The US Food and Drug Administration’s (FDA) oncology drugs advisory committee (ODAC) voted 12-0 to endorse the use of minimal residual disease (MRD) at 10-5 in complete responders (CR) as an intermediate endpoint for accelerated approval, potentially opening the door to new trial designs for blood cancer drugs. 15 April 2024
As the first drug to reach the US market for the treatment of Staphylococcus aureus bacteremia (SAB) in over 15 years, Swiss drugmaker Basilea Pharmaceutica's (SIX: BSLN) Zevtera (ceftobiprole medocaril), will play a unique and critical role in the future management of this serious, and commonly fatal infection. 12 April 2024
The European Parliament has formally adopted new pharmaceutical legislation, including proposals for a new directive and a new regulation. 11 April 2024
The US Food and Drug Administration has given a green light to BrainStorm Cell Therapeutics for the design of a Phase IIIb trial of NurOwn (MSC-NTF cells). 10 April 2024
Research suggests there will likely be strong uptake for the first USA-approved therapy for metabolic dysfunction-associated steatohepatitis (MASH). 9 April 2024
The US regulator has once more rebuffed efforts on the part of Supernus Pharmaceuticals to register its Parkinson’s disease candidate SPN-830. 9 April 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