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Biosimilars
The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025
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Pharmaceutical
The International Finance Facility for Immunization (IFFIm) has announced the settlement of its £300 million ($407 million), three-year 4.25% fixed-rate bond that was announced on June 3. 14 June 2025
Biotechnology
The Food and Drug Administration approved US pharma giant Merck & Co’s mega-blockbuster cancer drug Keytruda (pembrolizumab) for a new indication. 13 June 2025
Pharmaceutical
Germany’s Merck KGaA has presented detailed results from cohort B of the global Phase II WILLOW study of enpatoran, an investigational, oral, novel TLR7/8 inhibitor in systemic lupus erythematosus (SLE). 13 June 2025
Biotechnology
US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), the company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. 13 June 2025
Pharmaceutical
UK pharma major GSK today revealed that it has licensed its Shigella vaccine candidate, altSonflex1-2-3, to India’s Bharat Biotech International (BBIL). 13 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Pharmaceutical
The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma, for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 13 June 2025
Biotechnology
COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
Generics
Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent. 12 June 2025
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Biotechnology
South Korea’s LigaChem Biosciences has signed two antibody licensing agreements with US biotech NovaRock Biotherapeutics, reports Korea Biomedical Review. 12 June 2025
Latest Relevant Ones To Watch News
COVID success story BioNTech is to buy fellow German mRNA company CureVac. 12 June 2025
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