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INSIGHTS+

The US FDA New Drug Approvals in January 2026 

Shots:  Approval numbers were lower, but the impact remained strong the FDA cleared one new drug in January 2026 versus three in January 2025, reflecting continued innovation in areas of high unmet need  Zycubo from Sentynl Therapeutics was approved for pediatric Menkes disease, offering a targeted treatment for this rare, life-threatening genetic copper deficiency disorder  Clinical results were striking, showing…
February 10, 2026

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NEWS

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The US FDA has approved Darzalex FASPRO (daratumumab and hyaluronidase-fihj) + bortezomib, lenalidomide & dexamethasone (D-VRd) for adults with NDMM who are ineligible for autologous stem cell transplant. Approval was based on the P-III (CEPHEUS) trial, assessing D-VRd vs VRd in 395 ASCT-ineligible or deferred patients across 13 countries in the EU, North America,…
January 28, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2025   

Shots:  Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact.  In December 2025, the EMA…
January 20, 2026

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INSIGHTS+

The US FDA New Drug Approvals in December 2025 

Shots:  Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision  Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…
January 13, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in November 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks  In…
December 16, 2025

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NEWS

Metsera Declares Novo Nordisk’s ~$9B Acquisition Proposal a Superior Offer to Pfizer Merger Agreement

Shots: Metsera has declared Novo Nordisk’s unsolicited ~$9B acquisition proposal, valuing shares up to $77.75, as a “Superior Company Proposal” than its existing Pfizer Merger Agreement The 2-step proposal incl. an initial $56.5/share cash payment & issuance of non-voting preferred stock for 50% of Metsera’s share capital, followed by a CVR of ~$21.25/share in cash…
October 31, 2025

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VIEWPOINTS

Breaking New Ground in Oncology: Leonard Mazur from Citius Pharmaceuticals in Conversation with PharmaShots 

Shots:   Citius Pharmaceuticals celebrates its first-ever FDA approval with Lymphir, a novel therapy for relapsed or refractory cutaneous T-cell lymphoma     In an exclusive conversation, Leonard Mazur, Co-Founder and CEO at Citius Pharmaceuticals, shares insights on Lymphir’s launch strategy and its potential impact on the oncology landscape    Leonard also highlights Mino-Lok, Citius’ innovative…
October 6, 2025

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Innovative Minds Psychedelics in Medicine
MAGAZINE

PharmaShots Magazine-September-2025 Edition

Medical psychedelics are a fascinating field that modern science has yet to comprehend completely. Researchers are still digging up, trying to find evidence-based outcomes to tap into a whole new opportunity in psychiatry and mental health medicines The September Edition unearths a brand-new perspective on psychedelics through engaging articles, illustrative infographics, trailing BioTrends, illuminating regulatory…
September 11, 2025

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