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,…

ByDipanshu Dixit1 day ago

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Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Shots: The US FDA has approved Pfizer's Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl.…

ByRidhi Rastogi1 day ago

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Pfizer Licenses Chai Discovery’s AI Platform to Accelerate Biologics Research

Shots: Pfizer & Chai Discovery have entered into a licensing agreement, allowing Pfizer to integrate Chai’s AI-driven drug discovery platform into its biologics research workflows As per the deal, Pfizer will integrate Chai’s AI platform into its drug discovery engine, gaining early access to the Chai-3 model & a customized AI model built using Pfizer’s…

ByRidhi RastogiJune 5, 2026

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Pfizer and Innovent Biologics Partner to Accelerate 12 Oncology Programs in a Deal Valued at ~$10.5B

Shots: Innovent will advance the early-stage & de novo cancer therapies, incl. ADCs through P-I before Pfizer assumes global development, with Pfizer securing exclusive global rights to 4 programs & will be responsible for the global development costs Also, Pfizer will obtain exclusive ex-Greater China rights to 4 additional programs & fund the majority of development…

ByRidhi RastogiMay 29, 2026

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Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Astellas' Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states Opinion was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or…

ByRidhi RastogiMay 22, 2026

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Pfizer Reports the P-II Trial Data on PF-07872412 to Prevent Pneumococcal Disease at ISPPD 2026

Shots: Pfizer has reported its P-II trial data assessing the safety, tolerability & immunogenicity of a 4 dose series of PF-07872412 (25vPnC) vs 4 doses of PREVNAR 20 at mos. 2, 4, 6 & 12-15 in infants 25vPnC vaccine generated higher immune responses against serotype 3 vs Prevnar 20, with geometric mean titers 8.8-fold higher…

ByRidhi RastogiMay 20, 2026

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Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Shots: The EC has approved Pfizer's Hympavzi (marstacimab; QW, SC) for the treatment of pts (≥12yrs., ≥35kg) with hemophilia A with FVIII inhibitors or hemophilia B with FIX inhibitors, based on P-III (BASIS) study During the active treatment period, Hympavzi achieved a 93% reduction in mean treated ABR vs on-demand therapy (1.39 vs 19.78), plus…

ByRidhi RastogiMay 13, 2026

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Rigel Signs ~$445M Licensing Pact with Arvinas and Pfizer for Veppanu

Shots: Rigel has entered into an exclusive, global license agreement with Arvinas & Pfizer to develop, manufacture & commercialize FDA-approved Veppanu (vepdegestrant) for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. As per the deal, Rigel will pay Arvinas & Pfizer $70M upfront, $15M in upon completion of transition activities, & ~$320M in milestones plus tiered royalties…

ByRidhi RastogiMay 12, 2026

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Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

Shots: Pfizer has reported the P-III (MagnetisMM-5) trial data assessing Elrexfio monotx. (SC) vs daratumumab + pomalidomide & dexamethasone for the treatment of adults (n= 497) with r/r MM who received prior ≥1L of treatment Trial met its 1EP of improved PFS, as assessed by BICR, while OS data (2EP) remain immature & is under assessment; data…

ByRidhi RastogiMay 1, 2026

TOP 20

Top 20 Biopharma Deal Terminations of 2025

Shots: Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…

ByPrince GiriApril 24, 2026

The US FDA New Drug Approvals in May 2026

Pfizer Receives the US FDA Approval for Hympavzi to Treat Hemophilia A or B in Two Populations

Pfizer Licenses Chai Discovery’s AI Platform to Accelerate Biologics Research

Pfizer and Innovent Biologics Partner to Accelerate 12 Oncology Programs in a Deal Valued at ~$10.5B

Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Pfizer Reports the P-II Trial Data on PF-07872412 to Prevent Pneumococcal Disease at ISPPD 2026

Pfizer Receives the EC Approval for Hympavzi to Treat Hemophilia A and B

Rigel Signs ~$445M Licensing Pact with Arvinas and Pfizer for Veppanu

Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

Top 20 Biopharma Deal Terminations of 2025

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