PFE Pfizer

Medicus Pharma signs co-development deal with Pfizer for CD228V ADC

Medicus Pharma gains exclusive worldwide rights to develop and commercialize Pfizer's early-stage CD228V antibody-drug conjugate under a co-development agreement. The deal includes $12M upfront, $15M anniversary payment, $2M development funding, and potential milestones exceeding $1B plus low double-digit royalties. Pfizer retains patent ownership and an option to co-fund pivotal trials but Medicus controls all development and regulatory decisions.

Pfizer/BioNTech receive FDA approval for XFG-adapted COVID-19 vaccine

FDA approved the supplemental BLA for the 2026-2027 XFG-adapted COMIRNATY formula. The vaccine is now authorized for adults 65+ and high-risk individuals 5-64 years. Shipping begins immediately, replacing prior formulations.

Rigel in-licenses VEPPANU (vepdegestrant) from Arvinas/Pfizer

Rigel signed an exclusive global license for the first FDA-approved PROTAC, vepdegestrant, for 2L+ ER+/HER2-, ESR1-mutated mBC. The deal closed June 11, 2026 with a $70 million upfront payment; U.S. commercial launch is slated for mid-August 2026.

Pfizer: LITFULO Phase 3 topline positive in nonsegmental vitiligo

Two pivotal Phase 3 trials (TRANQUILLO, TRANQUILLO 2) met co-primary endpoints, showing statistically significant facial and total-body repigmentation versus placebo at Week 52. Pfizer plans to submit global regulatory filings for LITFULO as an oral systemic therapy for adults with nonsegmental vitiligo.

Pfizer: FDA sets Q4 2026 PDUFA for TALZENNA + XTANDI mCSPC sNDA

FDA accepted the sNDA for Priority Review and assigned a PDUFA action date in Q4 2026. The filing seeks to expand the TALZENNA + XTANDI label from mCRPC to HRR gene-mutated mCSPC. The application is supported by Phase 3 TALAPRO-3 data showing a 52% reduction in radiographic progression or death versus placebo + XTANDI.

FDA approves PADCEV + Keytruda for MIBC neoadjuvant/adjuvant use

FDA approved PADCEV plus Keytruda as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer regardless of cisplatin eligibility. This expands the prior November 2025 approval (limited to cisplatin-ineligible patients) to all MIBC patients, establishing the first platinum-free regimen in this setting.

Pfizer: FDA approves IBRANCE for HR+, HER2+ metastatic breast cancer maintenance

FDA approved IBRANCE (palbociclib) plus trastuzumab ± pertuzumab and endocrine therapy as maintenance for HR+, HER2+ locally advanced or metastatic breast cancer after induction. This is the first CDK4/6 inhibitor approval for HR+ metastatic breast cancer regardless of HER2 status, expanding IBRANCE’s label beyond its prior HR+, HER2- indications.

Merck: EC approves KEYTRUDA + Padcev for cisplatin-ineligible MIBC

The European Commission has approved KEYTRUDA plus Padcev as the first PD-1 inhibitor plus ADC regimen for perioperative use in cisplatin-ineligible resectable MIBC. The approval is based on KEYNOTE-905/EV-303 Phase 3 data showing 60% reduction in EFS events and 50% reduction in death versus surgery alone. This follows a positive CHMP recommendation in May 2026 and mirrors the FDA approval granted in November 2025.

Pfizer: SigVie-002 Phase 3 topline for sigvotatug vedotin misses OS endpoint

The Phase 3 SigVie-002 study did not meet its primary overall-survival endpoint versus docetaxel in the overall previously-treated non-squamous NSCLC population. A numerically stronger OS and PFS trend was observed in the pre-specified subgroup that had received only one prior line of therapy. Pfizer will continue development in earlier lines and in combination with pembrolizumab.

Zai Lab: China NMPA approves TIVDAK for recurrent/metastatic cervical cancer

China NMPA approved the BLA for TIVDAK (tisotumab vedotin) for adult patients with recurrent or metastatic cervical cancer after chemotherapy. The approval is supported by the global Phase 3 innovaTV 301 trial showing OS benefit (HR 0.70) and consistent China subpopulation results (HR 0.55). TIVDAK becomes the first ADC approved in China for this indication.

Pfizer HYMPAVZI gains FDA approval for hemophilia A/B ages 6+ with/without inhibitors

FDA approved expanded indication for HYMPAVZI (marstacimab-hncq) to include patients 12 years and older with inhibitors and pediatric patients 6-11 years with or without inhibitors. This makes HYMPAVZI the first subcutaneous non-factor therapy available for pediatric hemophilia B patients ages 6-11.

Merck: Positive EU CHMP Opinion for KEYTRUDA + Padcev in MIBC

CHMP issued a positive opinion recommending approval of KEYTRUDA plus Padcev as perioperative treatment for cisplatin-ineligible resectable MIBC. The opinion is based on statistically significant improvements in EFS, OS, and pCR from the Phase 3 KEYNOTE-905 trial. The European Commission decision is expected in Q3 2026.

Pfizer: EC approves HYMPAVZI for hemophilia A/B with inhibitors

The European Commission granted marketing authorization for HYMPAVZI (marstacimab) in adults and adolescents ≥12 years (≥35 kg) with hemophilia A or B and inhibitors. The approval is based on Phase 3 BASIS data showing 93% reduction in treated ABR versus on-demand therapy and sustained low bleeding rates in the open-label extension.

Arvinas: FDA approves VEPPANU (vepdegestrant) for ESR1-mutated breast cancer

FDA granted full approval for VEPPANU (vepdegestrant) in ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer after ≥1 line of endocrine therapy. Approval was received ahead of the June 5, 2026 PDUFA date and marks the first FDA-approved PROTAC degrader. Arvinas will receive a $50 million development milestone payment from Pfizer, offset by amounts owed to Yale.

Arvinas, Inc · FDA approves Veppanu (vepdegestrant)

FDA lists Veppanu (vepdegestrant) as novel drug approval #13 of 2026 on 2026-05-01: To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy

Labcorp launches Agilent PD-L1 IHC 22C3 pharmDx for KEYTRUDA in ovarian cancer

Labcorp has made the FDA-approved PD-L1 IHC 22C3 pharmDx companion diagnostic available nationwide to identify patients with platinum-resistant ovarian cancer eligible for KEYTRUDA. The test supports the February FDA approval of KEYTRUDA plus paclitaxel (with or without bevacizumab) for PD-L1+ (CPS ≥1) patients who have received one or two prior systemic regimens. This enables rapid identification of eligible patients following the Phase 3 KEYNOTE-B96 trial results showing improved PFS and OS.

Merck: FDA sets Aug 17 2026 PDUFA for KEYTRUDA + Padcev in cisplatin-eligible MIBC

FDA granted Priority Review and set a PDUFA target action date of August 17, 2026 for two sBLAs: KEYTRUDA plus Padcev and KEYTRUDA QLEX plus Padcev in cisplatin-eligible MIBC. If approved, these would be the first perioperative regimens for MIBC regardless of cisplatin eligibility, expanding from the existing cisplatin-ineligible approval.

Merck: EC approves KEYTRUDA + paclitaxel ± bevacizumab in PD-L1+ platinum-resistant ovarian cancer

The European Commission granted marketing authorization for pembrolizumab plus paclitaxel ± bevacizumab in adults with PD-L1 (CPS ≥1) platinum-resistant recurrent ovarian carcinoma after 1-2 prior regimens. This is the first PD-1 inhibitor-based regimen approved in the EU for this indication, supported by statistically significant PFS and OS gains in KEYNOTE-B96.

Pfizer/Valneva PF-07307405 Phase 3 VALOR trial shows >70% Lyme efficacy

The Phase 3 VALOR trial met its pre-specified secondary efficacy endpoint with 73.2% efficacy from 28 days post-dose 4 and 74.8% from 1-day post-dose 4. Although the primary endpoint's 95% CI lower bound fell short of the pre-specified >20 criterion, Pfizer views the clinically meaningful efficacy as sufficient to proceed with regulatory submissions.

Pfizer: Phase 2 FOURLIGHT-1 topline positive for atirmociclib in 2L HR+/HER2- MBC

The randomized Phase 2 FOURLIGHT-1 study met its primary PFS endpoint, showing a statistically significant 40% reduction in risk of progression or death (HR 0.60, p=0.0007) versus control in patients progressing soon after prior CDK4/6 inhibitor therapy. The data support advancing atirmociclib into first-line metastatic and early-stage settings, with a Phase 3 first-line study already ongoing.

Verastem: RAMP 301 Phase 3 topline data expected mid-2027

The corporate presentation states that the RAMP 301 confirmatory Phase 3 trial of avutometinib + defactinib versus investigator’s choice therapy in recurrent LGSOC will report topline data by mid-2027. This readout is intended to confirm the RAMP 201 results in KRAS-mutant patients and potentially expand the approved indication to all KRAS mutation statuses.

Arvinas: FDA sets June 5, 2026 PDUFA for vepdegestrant NDA

The FDA has accepted the NDA for vepdegestrant and assigned a PDUFA action date of June 5, 2026. Arvinas and Pfizer will jointly select a third-party commercial partner to maximize launch potential if approved.

Merck receives FDA approval of KEYTRUDA QLEX subcutaneous injection

The document states that Merck received FDA approval for KEYTRUDA QLEX Injection for subcutaneous use across all solid tumor indications for KEYTRUDA. This converts an existing intravenous biologic into a subcutaneous formulation, expanding the delivery options for the same asset without altering the approved indications.

Arvinas presents VERITAC-2 PRO data at ESMO 2025

Arvinas presented new patient-reported outcomes data from the Phase 3 VERITAC-2 trial of vepdegestrant at ESMO 2025. The data showed statistically significant reduced risk of deterioration versus fulvestrant in ESR1-mutated patients across multiple domains. Additional Phase 2 TACTIVE-N neoadjuvant data were also presented at the same congress.

Merck & Co., Inc. · FDA licenses Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)

FDA's Purple Book lists BLA 761467 (Keytruda Qlex, pembrolizumab and berahyaluronidase alfa-pmph; Merck Sharp & Dohme LLC, CDER) as licensed on 2025-09-19.

Arvinas: vepdegestrant NDA PDUFA set for June 5, 2026

The FDA has assigned a PDUFA action date of June 5, 2026 for the NDA of vepdegestrant as monotherapy in ESR1-mutant ER+/HER2- advanced or metastatic breast cancer. Arvinas and Pfizer have agreed to out-license commercialization rights to a third party rather than co-commercialize themselves.