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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,…
2 days 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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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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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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NEWS

Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing

Shots: Piramal Pharma Solutions has entered into a strategic collaboration with Ajinomoto Bio-Pharma Services to support antibody-drug conjugate (ADC) development and manufacturing programs Under the agreement, Piramal will refer customers to Ajinomoto’s AJICAP platform for site-specific ADC conjugation, while Ajinomoto will direct clients to Piramal for CDMO manufacturing services across development and commercialization The collaboration…
April 17, 2026

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NEWS

Mabwell  Collaborates with a Strategic Business Partner to Commercialize of Mailishu and Maiweijian (Biosimilar, Prolia and Xgeva) in Malaysia   

Shots:  Mabwell has entered a licensing and commercialization agreement with a Malaysian partner for its denosumab biosimilars, Mailishu (biosimilar, Prolia) and Maiweijian (biosimilar, Xgeva)  As per the deal, the partner will handle registration and commercialization in Malaysia  While Mabwell will oversee the development, manufacturing, and supply of the products  Ref: Mabwell |  Image:  Mabwell |  Press Release Related News:  Mabwell Initiates P-III Trial for 9MW2821 in TNBC…
April 16, 2026

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NEWS

Mochida Pharmaceutical Collaborates with Qilu Pharmaceutical to Develop & Commercialize of Follitropin Alfa (Biosimilar, Gonal‑f) Across Japan 

Shots:  Mochida Pharmaceutical has entered into a development and commercialization agreement with Qilu Pharmaceutical for a biosimilar of follitropin alfa in Japan  As per the deal, Mochida will lead development to secure marketing approval in Japan, collaborating with Qilu for early launch, and strengthening its position in Japan’s biosimilar market  Follitropin alfa is a recombinant FSH used for…
April 15, 2026

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INSIGHTS+

The US FDA New Drug Approvals in March 2026 

Shots:  Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact.  Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…
April 14, 2026

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