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Abbvie
NEWS

AbbVie Reports EMA Filing for Skyrizi SC Induction to Treat Active Crohn’s Disease

Shots: The EMA has received an application seeking approval for Skyrizi (risankizumab; SC induction) for the treatment of adults with moderately to severely active Crohn's disease (CD) Application was backed by the P-III (AFFIRM) trial assessing Skyrizi (SC) as an induction treatment in above-mentioned pts (n=289) in 3 periods: Period A compared Skyrizi against PBO for 12wks., blinded…
3 days ago

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INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2026    

Shots:  The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.  EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…
August 18, 2026

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Fresenius Kabi
NEWS

Fresenius Kabi Reports FDA and EMA Acceptance of PB016 (Biosimilar, Entyvio) for Review

Shots: The US FDA and EMA have accepted the BLA & MAA, respectively, for PB016, a biosimilar version of Entyvio (vedolizumab) lyophilized vial for IV administration BLA was supported by an extensive development program assessing PB016 vs Entyvio, to evaluate its similarity to the reference product, consistent with regulatory requirements for biosimilar approval PB016 is…
August 3, 2026

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Amgen
NEWS

CHMP Recommends Expanded EU Indication for Amgen’s Repatha to Reduce First Heart Attack and Stroke Risk In Adults

Shots: Amgen announced that the CHMP issued a positive opinion recommending an expanded indication for Repatha (evolocumab) to reduce cardiovascular risk in adults with established or high risk for atherosclerotic cardiovascular disease by lowering LDL-C levels, alongside correction of other risk factors The recommendation is supported by the P-III (VESALIUS-CV) study involving  ≥12,000 pts., Repatha…
July 31, 2026

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NEWS

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Shots: The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which…
July 23, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
July 21, 2026

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NEWS

Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older

Shots: The EMA has accepted a submission to extend marketing authorization of Ebglyss (lebrikizumab) to pts (6mos. to <18yrs., weighing <40kg) with mod. to sev. atopic dermatitis Application was supported by interim data from the pediatric clinical program, incl. the ADorable-1 evaluating Ebglyss in pts (6mos. to <18yrs.), & the ADorable-2 LTE study assessing safety…
July 20, 2026

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MAGAZINE

PharmaShots Magazine-July-2026 Edition

Shots: This edition explores AI-Powered Pharmaceutical Logistics, highlighting how artificial intelligence, predictive analytics, robotics, IoT, and digital twins are transforming pharmaceutical supply chains into intelligent, resilient, and patient-centric networks that optimize forecasting, manufacturing, warehousing, and global distribution. Through expert perspectives, feature stories, and regulatory insights, we examine the opportunities and challenges of AI-enabled pharmaceutical logistics—from…
July 9, 2026

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