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INSIGHTS+

The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
1 day ago

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VIEWPOINTS

Jared Kelly on Immune Priming & Survival Outcomes: Oncolytics Biotech’s Vision for Pelareorep

Shots:  Oncolytics Biotech is advancing pelareorep beyond the traditional standalone therapy model, positioning the platform as a potential immune-priming backbone capable of enhancing immunotherapies, checkpoint inhibitors, chemotherapies, and other oncology treatments across multiple difficult-to-treat tumor settings.  The company continues generating growing survival and immune-engagement data across colorectal, pancreatic, and anal cancers, while emphasizing pelareorep’s potential to “turn cold tumors…
June 3, 2026

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NEWS

Wockhardt Receives US FDA Approval for Zaynich to Treat cUTI Including Pyelonephritis 

Shots:  The US FDA has approved Zaynich (Cefepime and Zidebactam) for treating adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria  Approval was based on a P-III (ENHANCE-1) trial in 530 adults with cUTI or acute pyelonephritis across 64 global sites, where Zaynich demonstrated superior clinical and microbiological response rates vs. meropenem (89.0% vs. 68.4%) and was generally well tolerated  Zaynich is an injectable…
May 29, 2026

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THOUGHTSPOT

Is Immune Priming the Missing Piece in Oncology? Oncolytics Biotech Thinks So

The oncology landscape is increasingly recognizing that the future of cancer treatment may depend just as much on immune engagement and combination strategies as on standalone therapeutic activity.  That shift in thinking is shaping much of the scientific attention surrounding pelareorep, the lead immunotherapeutic candidate being advanced by Oncolytics (NASDAQ: ONCY).  For years, oncology drug candidates were largely evaluated through…
May 28, 2026

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EVENTS

Evolution Summit 2026 | Sep 28-29 | Park Hyatt Aviara Resort, San Diego, CA

The Evolution Summit returns September 28-29, 2026 at Park Hyatt Aviara Resort, Golf Club & Spa, San Diego, CA, bringing together leading clinical trial executives with innovative suppliers and solution providers in an invitation-only, premium setting.  Expect visionary keynotes, real-world case studies, and interactive forums aligned to the most pressing challenges in clinical operations and…
May 26, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in April 2026    

Shots:  The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma  CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS  The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…
May 19, 2026

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NEWS

Alteogen Reports the MFDS Approval of Eyzanfy (Biosimilar, Eylea) 

Shots:  The Korean MFDS has approved Eyzanfy (ALT-L9), a biosimilar version of Eylea (aflibercept)  In 2025, ALT-L9 received EC approval as a brand name of Eyluxvi  Approval was based on P-III trial across 12 countries in 431 wAMD pts, demonstrating Eyluxvi’s efficacy, safety, and therapeutic equivalence comparable to Eylea  Ref: Alteogen | Image: Alteogen | Press Release Related News:- Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s…
May 15, 2026

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NEWS

IQVIA and Kexing Biopharm Strengthen Strategic Collaboration to Advance Global Biosimilar Development through AI-enabled Capabilities 

 Shots:  IQVIA is expanding its collaboration with Kexing Biopharm to advance a global multi-product biosimilar development and commercialization program  As part of the collaboration, IQVIA will provide end-to-end development, regulatory, analytics, and commercialization support to accelerate Kexing’s global biosimilar expansion while maintaining high quality and scientific standards  The collaboration also integrates IQVIA’s AI-enabled clinical trial capabilities to streamline protocol design, site selection,…
May 13, 2026

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INSIGHTS+

The US FDA New Drug Approvals in April 2026 

Shots:  Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.  Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…
May 12, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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