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Amneal receives FDA tentative approval for beclomethasone dipropionate HFA inhalation aerosol

Written by | 7 Nov 2025

Amneal Pharmaceuticals, Inc. announced that the FDA has tentatively approved the Company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol (40 mcg/actuation and 80 mcg/actuation)…. read more.

Johnson & Johnson to advance robotics development with NVIDIA Isaac for healthcare

Written by | 6 Nov 2025

Johnson & Johnson MedTech announced advancements in developing the company’s robotics systems with physical artificial intelligence (AI) technologies that create simulated environments to accelerate future product innovation, optimize… read more.

Teva and Prestige Biopharma enter license agreement for Tuznue (trastuzumab biosimilar) commercialization in Europe

Written by | 4 Nov 2025

Teva Pharmaceutical Industries Ltd. entered into a license agreement with Prestige Biopharma, for the commercialization of Tuznue (trastuzumab), a biosimilar to Herceptin, across a majority of European markets…. read more.

Xtandi (enzalutamide) plus leuprolide reduced risk of death by 40% vs leuprolide alone in men with a type of advanced prostate cancer – Pfizer

Written by | 3 Nov 2025

Pfizer Inc and Astellas announced final overall survival (OS) results from the Phase III EMBARK study evaluating Xtandi (enzalutamide), in combination with leuprolide and as monotherapy, in men with… read more.

Agreement announced with U.S. Government to expand access to IVF-Therapies including Gonal-f, Ovidrel and Cetrotide – Merck

Written by | 31 Oct 2025

Merck KGaA announced that EMD Serono, their healthcare business of Merck in the U.S. and Canada, and U.S.-President Donald J. Trump’s administration entered into an agreement to expand… read more.

Leqembi IQLIK (lecanemab-irmb) subcutaneous autoinjector named as one of TIME’s “Best Inventions of 2025” – Eisai + Biogen

Written by | 30 Oct 2025

Eisai Co., Ltd. and Biogen Inc. announced that Leqembi IQLIK, a subcutaneous autoinjector formulation of lecanemab (generic name), for the treatment of Alzheimer’s disease (AD) has been selected… read more.

Rinvoq (upadacitinib) demonstrated superiority versus Humira (adalimumab) for primary endpoint in a head-to-head study in rheumatoid arthritis patients who have failed first TNF Inhibitor – AbbVie

Written by | 29 Oct 2025

AbbVie announced positive topline results from the Phase IIIb/IV head-to-head SELECT-SWITCH study evaluating the efficacy and safety of upadacitinib (Rinvoq) 15 mg, once daily, compared to adalimumab (Humira)… read more.

Tzield accepted for expedited review by FDA for stage 3 type 1 diabetes through Commissioner’s National Priority Voucher pilot program – Sanofi

Written by | 28 Oct 2025

The FDA has accepted for expedited review the supplemental biologics license application (sBLA) for Tzield (teplizumab-mzwv) to delay the progression of stage 3 type 1 diabetes (T1D) in… read more.

CHMP adopts a positive opinion for change to the terms of the marketing authorisation for Tremfya (guselkumab) – Johnson & Johnson

Written by | 27 Oct 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Tremfya (guselkumab). The marketing… read more.

CHMP adopts a positive opinion for change to the terms of the marketing authorisation for Breyanzi (isocabtagene maraleucel) – BMS

Written by | 26 Oct 2025

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Breyanzi. The marketing authorisation… read more.

Verzenio (abemaciclib) prolonged survival in HR+, HER2-, high-risk early breast cancer with two years of treatment – Eli Lilly

Written by | 25 Oct 2025

Eli Lilly and Company announced results from the primary overall survival (OS) analysis of the Phase III monarchE trial showing that two years of adjuvant Verzenio plus endocrine… read more.

Pyrukynd (mitapivat) Receives Positive CHMP Opinion for Adults with Thalassemia – Agios Pharmaceuticals

Written by | 24 Oct 2025

Agios Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion for the new indication for Pyrukynd… read more.

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