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The EU approval of Vueway for neonates, infants, and toddlers is a milestone for pediatric imaging as it allows high-quality MRI imaging at half the GBCA dose, supporting reduced gadolinium exposure in vulnerable young patients
Vueway’s gadopiclenol demonstrates safety and diagnostic performance by offering high stability, low dissociation risk, and 2.5–4× greater relaxivity than other macrocyclic GBCAs, enabling effective imaging…
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Lynozyfic is emerging as a standout in heavily pre-treated multiple myeloma. In the pivotal LINKER-MM1 trial, it delivered early, deep, and durable responses, offering renewed hope for patients with limited options. Its response-adapted dosing regimen further reduces treatment burden and enhances convenience
Regeneron is accelerating progress with a broad development strategy, advancing Lynozyfic across multiple therapy lines, combination regimens, precursor conditions, and global markets. The program…
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The EC has approved Cosmo Pharmaceuticals and Glenmark Pharmaceuticals’ Winlevi (clascoterone 10 mg/g cream) for the Treatment of Acne Vulgaris in 17 countries in Europe
Winlevi is authorized in the EU for treating acne vulgaris in adults and adolescents aged 12 to <18 years, with adolescent use limited to facial application
Following approval, Glenmark will begin commercializing Winlevi across 17 European countries, including Belgium, France, Spain,…
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Following the US FDA approval, EMA's CHMP issued a positive opinion of Brukinsa (zanubrutinib) film‑coated tablets for all approved indications. EC will now review the opinion for MAA in the EU, Norway, and Iceland
BRUKINSA tablets (160mg) are bioequivalent to the capsule form, supported by a P-I study. With a recommended daily dose of 320mg,…
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The EC approved 10 New Chemical Entities in April 2024, leading to treatments for patients and advances in the healthcare industry
In April 2024, the major highlighted drugs were Takeda’s Fruzaqla to treat Adults with mCRC and Johnson & Johnson’s Rybrevant for the treatment NSCLC
PharmaShots has compiled a list of 5 drugs that have received positive…
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The EC approved 1 Biologic and 11 New Chemical Entities in March 2024, leading to treatments for patients and advances in the healthcare industry
In March 2024, the major highlighted drugs were Novartis’ Fabhalta to treat PNH and UCB’s Bimzelx for the treatment of Adults with Moderate to Severe Hidradenitis Suppurativa
PharmaShots has compiled…
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The EMA approved 2 BLA and 6 New Chemical Entities in January 2024, leading to treatments for patients and advances in the healthcare industry
In January 2024, the major highlighted drugs were Padcev to treat Bladder Cancer and Eylea for the treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)
PharmaShots has…
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The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry
In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis
PharmaShots has compiled a list of a…

