Bavarian Nordic Reports EC Approval of Imvanex Against Smallpox & Mpox for Children Aged 2 to Less than 12 Years

Shots: The EC has approved type II variation MAA for Imvanex (MVA-BN) smallpox & mpox vaccine, extending its use to include children aged 2 to less than 12yrs. Approval was based on P-II trial data involving 227 children (2 to <12yrs.) & 224 adults, which showed non-inferior immune responses & a similar safety profile in children…

ByRidhi Rastogi3 days ago

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The US FDA Approves Moderna’s mFLUSIVA Against Seasonal Influenza for Adults Aged 50 or More

Shots: FDA approved mFLUSIVA against seasonal influenza for use in adults (≥50yrs); supply to select retailers to be available in coming wks. Regulatory review is ongoing in the EU, Canada & Australia, with flings in other countries planned during 2026 Approval in pts (50–64yrs.) was backed by a P-III trial (n=40,805; ≥50yrs.) assessing safety &…

ByRidhi Rastogi4 days ago

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Takeda Reports US FDA Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Shots: The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. DEA scheduling decision is expected within 90 days, after which it will be available through a specialty pharmacy Approval was based on extensive data, incl. P-III (FirstLight & RadiantLight) trial assessing Orzeyful (BID) in…

ByRidhi Rastogi4 days ago

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Sanofi Reports the EC Approval of MenQuadfi for Use in Infants from Age 6 Weeks Against Invasive Meningococcal Disease

Shots: The EC has approved an extension of the indication of MenQuadfi to incl. infants (≥6wks.) for protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, & Y Approval was supported by extensive data from the MET58 clinical study, which evaluated the immunogenicity, safety, & tolerability of MenQuadfi in infants from 6wks. of…

ByRidhi RastogiAugust 4, 2026

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Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Shots: The US FDA has approved Garzulys (SC & IV), a biosimilar to NovoLog (insulin aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Garzulys was developed through a collaboration among Tonghua Dongbao, NKF, Xentria, Meitheal, & Emerge. Tonghua Dongbao developed the drug substance, NKF the drug product, Xentria led clinical…

ByRidhi RastogiAugust 3, 2026

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Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Shots: The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an androgen receptor pathway inhibitor (ARPI) for pts with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer Approval was based on the P-III (PSMAddition) trial, which showed Pluvicto + ARPI & ADT reduced the risk of progression or death by 28% vs SoC…

ByRidhi RastogiAugust 3, 2026

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Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The MHRA has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM MHRA assessment was based on P-III (SEQUOIA-HCM) trial of Myqorzo (n=282), showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min Additionally, NICE has recommended aficamten for eligible…

ByRidhi RastogiJuly 30, 2026

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Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…

ByRidhi RastogiJuly 30, 2026

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Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

Shots: The EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adults for whom topical corticosteroids (TCSs) & topical calcineurin inhibitors (TCIs) are inadequate or inappropriate Approval was based on the P-IIIb (TRuE-AD4) study assessing Opzelura vs vehicle in 241 adults with moderate AD, which met its co-1EPs of EASI75…

ByRidhi RastogiJuly 29, 2026

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AbbVie Secures EC Approval for Rinvoq to Treat Non-Segmental Vitiligo

Shots: The EC has approved Rinvoq (upadacitinib; 15mg, QD) for the treatment of pts (≥12yrs.) with non-segmental vitiligo (NSV) who are candidates for systemic therapy Approval was backed by the Viti-Up clinical program (M19-044; n=614), incl. 2 replicate trials assessing Rinvoq, where in Period A, pts were randomized to either Rinvoq or PBO for 48wks. &…

ByRidhi RastogiJuly 29, 2026

Bavarian Nordic Reports EC Approval of Imvanex Against Smallpox & Mpox for Children Aged 2 to Less than 12 Years

The US FDA Approves Moderna’s mFLUSIVA Against Seasonal Influenza for Adults Aged 50 or More

Takeda Reports US FDA Approval of Orzeyful (Oveporexton) for Narcolepsy Type 1

Sanofi Reports the EC Approval of MenQuadfi for Use in Infants from Age 6 Weeks Against Invasive Meningococcal Disease

Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)

Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

AbbVie Secures EC Approval for Rinvoq to Treat Non-Segmental Vitiligo

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