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October 4, 2024

FDA grants priority review for AstraZeneca’s Calquence sNDA

The US Food and Drug Administration (FDA) has accepted and granted priority review to AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

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The FDA will provide a decision on Calquence for the treatment of previously untreated mantle cell lymphoma by the first quarter of 2025. Credit: Narupon Promvichai from Pixabay.
October 1, 2024

FDA grants approval for Fresenius-Formycon’s biosimilar Otulfi

Otulfi is intended to treat Crohn’s disease, moderate to severe plaque psoriasis, ulcerative colitis and active psoriatic arthritis. Credit: Eszter Miller from Pixabay.
September 30, 2024

AbbVie seeks FDA approval for non-small cell lung cancer treatment

The company filed a BLA seeking accelerated approval for Teliso-V, targeting non-small cell lung cancer with c-Met overexpression. Credit: © AbbVie Inc. All rights reserved.

Contracts

August 9, 2024

Bavarian Nordic secures $156.8m US vaccine deal

The vaccine is marketed under various brand names. Credit: Mathurin NAPOLY / matnapo on Unsplash.

Boehringer Ingelheim receives EC conditional marketing approval for spesolimab

Marinus Pharmaceuticals signs collaboration agreement with Tenacia Biotechnology

Harbour BioMed, Moderna partner on immunotherapies development

Deals

Deals July 15, 2024

Merck enhances ophthalmology portfolio with EyeBio acquisition

Pharmaceutical Business Review

Biocon signs licensing and supply deal for diabetes drug in Brazil

Q32 Bio concludes merger deal with Homology Medicines

Zuellig Pharma acquires Cialis and Alimta brands from Lilly

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  4. Amgen’s TEPEZZA gets Japan’s MHLW approval for thyroid eye disease treatment
  5. FDA grants fast track designation for Elevation Oncology’s EO-3021

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