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FDA Chief Makary Defends Drug Calls as Report Flags Strained White House Ties

The dispute highlights tension between speedier approvals versus strict review rules.

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FDA Clears Vepdegestrant, First PROTAC Cancer Drug, for ESR1‑Mutated Breast Cancer

U.S. Prescription Drug Spending Set to Top $1 Trillion in 2026, ASHP Says

Canada Approves First Generic Ozempic, Clearing Dr. Reddy’s Semaglutide

Pfizer’s Elrexfio Posts Phase 3 PFS Win Over Standard Multiple Myeloma Regimen

Lilly’s Foundayo Start Trails Wegovy as Street Stays Positive

Novo Nordisk’s Oral Semaglutide Lowers HbA1c in Teens in Pivotal Trial

HHS Chief Distances From FDA Replimune Denial as Oncologists Dispute Review

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

FDA Grants Priority Review to Ifinatamab Deruxtecan for Pretreated Small Cell Lung Cancer

FDA Rejects Replimune’s Melanoma Virus Therapy Again for Insufficient Evidence

Peptide Craze Grows as HHS Chief Backs Wider Access

FDA Clears Lilly’s Foundayo Pill, Escalating GLP-1 Weight-Loss Rivalry

FDA Clears Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

Brazil Sets Deal to Produce Cancer Immunotherapy for the Public Health System

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

Delhi Court Pauses DRL’s ‘Olymviq’ Rollout in Ozempic Trademark Fight

Wave Life Sciences Shares Plunge 30% After Early Obesity Trial Readout

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

For Third Time, FDA Rejects Aldeyra’s Dry-Eye Drug Reproxalap Over Efficacy