Gilead’s lenacapavir moves closer to FDA approval for HIV PrEP use
Gilead is edging closer to an approval for its twice-yearly injectable human immunodeficiency virus-1 (HIV-1) capsid inhibitor, lenacapavir, as a …
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Valneva hits 2024 sales target but plans lower cash burn in 2025
Valneva has met its revenue growth target for 2024, fending off slower-than-expected sales for the chikungunya vaccine Ixchiq. The French vaccine …
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EC conditionally approves MSD’s Welireg for VHL disease and RCC
The European Commission (EC) has conditionally approved MSD's Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as a single agent …
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FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
Sanofi and Regeneron’s blockbuster biologic Dupixent (dupilumab) is poised for yet another label expansion, this time for the rare autoimmune …
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HMRI and Novartis Australia sign MoU to expedite medical research
The Hunter Medical Research Institute (HMRI) has signed a memorandum of understanding (MoU) with Novartis Australia for expediting medical research …
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FDA grants fast track status to Rznomics’ RZ-001 for HCC
The US Food and Drug Administration (FDA) has granted fast track designation to Rznomics' RZ-001 for the treatment of hepatocellular …
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Ono’s TGCT therapy wins FDA approval, challenging Daiichi Sankyo
Ono Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for its kinase inhibitor Romvimza (vimseltinib) to …
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Oncology and eClinical solutions: How one company is adapting to the challenges
Meticulous planning is central to building an effective clinical trial, powered by well-designed Interactive Response Technology (IRT) which provides not …
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Innate’s lacutamab gains FDA breakthrough therapy designation
Innate Pharma has secured US Food and Drug Administration (FDA) breakthrough therapy designation for lacutamab to treat adults with relapsed …
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Bispecific antibody startup Bambusa raises $90m to fund clinical trials
US-based startup Bambusa Therapeutics has secured $90m in Series A financing to advance its pipeline of bispecific antibodies for immunological …
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Bavarian Nordic scoops FDA approval for chikungunya vaccine in adults and teens
Bavarian Nordic has won US Food and Drug Administration (FDA) approval for its chikungunya vaccine Vimkunya, becoming the second company …
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GSK’s Penmenvy meningococcal vaccine gains FDA approval
GSK has secured approval from the US Food and Drug Administration (FDA) for its new vaccine, Penmenvy, to protect against …
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Moderna reports decline in Q4 2024 revenue
Moderna has reported revenue of $1bn for the fourth quarter (Q4) of 2024 - a sharp decline from the $2.8bn …
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EC approves CSL’s Andembry to stop hereditary angioedema attacks
CSL has received approval from the European Commission (EC) for Andembry (garadacimab) to prevent recurrent attacks of hereditary angioedema (HAE) …
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DMD market expected to grow to $5.2bn in the 7MM by 2033
The Duchenne muscular dystrophy (DMD) landscape across the seven major markets (7MM) - the US, France, Germany, Italy, Spain, the …
