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NEWS

DeepCyte Secures $1.5M to Advance AI-Driven Single-Cell Toxicology in Drug Development

Shots: DeepCyte, a techbio startup focused on advancing AI-powered toxicology for drug development, has officially launched with $1.5 million in seed funding, introducing two solutions to help biopharma teams detect, predict, and understand drug toxicity in human cells at single-cell resolution DeepCyte's MetaCore, a high-throughput single-cell metabolomics platform, leverages laser-based sampling and mass spectrometry to…
14 hours ago

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INSIGHTS+

Key Biosimilars Events of March 2026 

Shots:  Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.  Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
3 days ago

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PharmaShots Quarterly Outlook: The Forces Reshaping Biopharma in Q1 2026 

Headlines, Trends, and the Signals Shaping the Future of Biopharma  A Quarter That Reset the Biopharma Narrative  The first quarter of 2026 did not simply continue the momentum of the global biopharmaceutical industry; it redefined its direction.  From multi-billion-dollar acquisitions and accelerating rare disease breakthroughs to AI-powered discovery collaborations and gene therapy approvals, the industry demonstrated a clear shift toward precision innovation, strategic consolidation, and next-generation…
April 1, 2026

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The US FDA New Drug Approvals in February 2026 

Shots:  Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact.  Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia  Overall, February 2026 reflected…
March 10, 2026

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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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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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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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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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