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NEWS

VarmX Enrolls First Patient in P-III (EquilibriX-S) Trial of VMX‑C001 in Urgent Surgery

Shots: VarmX has enrolled the first pt in the global registrational P-III (EquilibriX-S) study assessing VMX-C001 vs usual pharmacologic care in pts receiving FXa inhibitors who require urgent surgery/procedures EquilibriX-S, a randomized, controlled trial is expected to recruit pts across >20 countries and assess whether a single IV dose of VMX-C001 rapidly restores hemostasis, with…
20 hours ago

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INSIGHTS+

The US FDA New Drug Approvals in July 2026 

Shots:  The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.   Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…
August 11, 2026

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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer

Shots: The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157) Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…
July 27, 2026

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INSIGHTS+

The US FDA New Drug Approvals in June 2026 

Shots:  The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment.  Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical…
July 14, 2026

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VIEWPOINTS

IL-33 Breakthrough in COPD: Caterina Brindicci and Frank Sciurba on Tozorakimab’s Phase III Success 

Shots:  Tozorakimab demonstrated a potential first-in-class advantage in COPD, becoming the first IL-33 biologic to achieve positive outcomes across three pivotal Phase III trials (OBERON, TITANIA, and MIRANDA), highlighting the clinical relevance of targeting both reduced and oxidized forms of IL-33 to reduce exacerbations in a broad patient population.  The LUNA Phase III programme enrolled the most comprehensive…
June 15, 2026

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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,…
June 9, 2026

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Sanofi
NEWS

Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Shots: Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination Nuvaxovid…
April 9, 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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Roche
NEWS

Roche Receives the Health Canada Approval for Gazyva to Treat Active Lupus Nephritis

Shots: Health Canada has approved Gazyva (obinutuzumab) for adults with active lupus nephritis receiving standard therapy Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC. Gazyva’s safety profile was consistent with its well-established profile from haematology-oncology indications Gazyva is…
January 28, 2026

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