FDA moves to remove suicide warnings from GLP-1 weight loss drugs
medicalxpress - Federal health regulators say popular weight loss drugs like Wegovy and Zepbound do not increase the risk of suicidal thoughts, and they have asked drugmakers to remove those warnings from medication labels.
AI Summary: In a surprising twist, the FDA has decided that the long‐rumored risk of suicidal ideation on popular GLP‑1 weight‐loss drugs may have been overblown. Regulators have now asked drugmakers – including Lilly and Novo Nordisk – to scrub these warnings from product labels, a move that is sure to spark both relief and raised eyebrows among critics.
Merck Could Strike 30 Billion Deal for Revolution Medicines
oncodaily - According to the Financial Times, Merck is in talks to acquire Revolution Medicines, a Redwood City, California-based cancer drug developer, in a deal that could value the company at roughly […]
AI Summary: Merck is reportedly in advanced talks to acquire Revolution Medicines—a Redwood City–based cancer drug developer—in a deal that could be worth around $30 billion. A separate report adds speculative color, reinforcing market buzz about this strategic move in oncology.
Aktis Has First Biotech IPO of 2026, Raising $318M to Expand the Reach of Radiopharmaceuticals
Frank Vinluan / medcitynews - Aktis Oncology’s IPO will support a pipeline of “miniprotein” radioconjugates that could offer advantages over other targeted radiation cancer treatments. In addition to its internal pipeline, Aktis has a discovery partnership with Eli Lilly. The post Akt…
AI Summary: Aktis Oncology’s debut on the public market raised $318M, buoyed by a 25% first‐day bounce. The IPO not only generated strong investor enthusiasm for biotech in 2026 but also signals the company’s ambitious plans to extend its portfolio of innovative miniprotein radioconjugates for targeted cancer therapy.
FDA rejects Corcept’s cortisol-targeting drug for Cushing’s syndrome
Ayisha Sharma / endpoints - Corcept Therapeutics failed to secure US approval for its drug candidate as a hormonal disorder treatment. The FDA rejected Corcept’s selective cortisol modulator relacorilant for Cushing’s syndrome, according to a company
AI Summary: Corcept Therapeutics has hit a regulatory roadblock as the FDA rejected its cortisol‐targeting relacorilant, intended for hormonal disorders. The decision forces the company to reassess its strategy, highlighting the challenges inherent in advancing novel hormonal therapies amid strict regulatory scrutiny.
Intratumoral Bacterial Burden Drives Immunotherapy Resistance in Head and Neck Cancer
oncodaily - Immune checkpoint blockade (ICB) benefits only a subset of patients with head and neck squamous cell carcinoma (HNSCC), and commonly used biomarkers (PD-L1, TMB) remain imperfect in this setting. This […]
AI Summary: Researchers reveal that an increased bacterial burden within head and neck tumors may undermine the efficacy of immune checkpoint blockade treatments. Detailed investigations indicate that intratumoral bacteria could be a pivotal factor in treatment resistance, opening new avenues for overcoming these challenges in managing advanced head and neck cancers.
Judge blocks 340B rebate pilot program
Ella Jeffries / beckershospitalreview - A federal judge granted a temporary restraining order blocking the Department of Health and Human Services from launching its 340B Rebate Model Pilot Program, which was scheduled to begin Jan. 1, 2026. U.S. District Judge Lance Walker of the District of M…
AI Summary: A federal judge has temporarily halted the rollout of a 340B rebate pilot program designed to reshape drug pricing ahead of its January start. The ruling challenges the current administration’s approach to reforming pricing models, casting uncertainty on the initiative’s future.
Advocates Applaud DEA’s Fourth Extension of Remote Prescribing Flexibilities
Marissa Plescia / medcitynews - The DEA extended telemedicine prescribing flexibilities for controlled substances through the end of 2026, drawing praise from telehealth advocates who are urging a permanent solution.The post Advocates Applaud DEA’s Fourth Extension of Remote Prescribing…
AI Summary: The Drug Enforcement Administration has extended telemedicine prescribing flexibilities for controlled substances through 2026, maintaining the COVID-era approach. Telehealth advocates are cheering the move as it cements remote care as a long-term fixture, even as regulators and critics continue debating its broader safety implications.
AstraZeneca bets up to $2B on Jacobio’s pan-KRAS inhibitor for cancer
Ayisha Sharma / endpoints - AstraZeneca is spending $100 million upfront to secure ex-China rights for an early-stage cancer drug developed by Jacobio Pharma. The UK drugmaker will be responsible for advancing and selling the oral pan-KRAS inhibitor, JAB-23E73, in ...
AI Summary: Reports indicate that AstraZeneca has struck a global licensing agreement with Jacobio Pharma for its investigational pan‑KRAS inhibitor. With a deal value of up to $2 billion and an upfront commitment, the move is set to reinforce AstraZeneca’s oncology pipeline with next‑generation targeted therapy.
Sanofi buys hepatitis B vaccine maker Dynavax for $2.2B; gets CRL for MS drug
Elizabeth Cairns / endpoints - Sanofi is set to supplement its vaccine offering with the acquisition of Dynavax Technologies for $2.2 billion in cash, the companies said Wednesday. Separately, Sanofi said the ...
AI Summary: Two separate reports confirm that Sanofi has completed a $2.2 billion deal to acquire Dynavax Technologies. This strategic move strengthens Sanofi’s vaccine lineup by adding a commercially proven hepatitis B vaccine and a clinical‐stage shingles candidate, positioning the company for enhanced market competitiveness amid global pressures.
Novo Nordisk’s Wegovy Pill Becomes First FDA-Approved Oral GLP-1 Drug for Weight Loss
Frank Vinluan / medcitynews - Beyond weight reduction and long-term maintenance of weight loss, the FDA decision for oral Wegovy covers use of the once-daily pill for reducing the risk of major cardiovascular events. Novo Nordisk expects the Wegovy tablet will launch in early January.…
AI Summary: The FDA has given its nod to Novo Nordisk’s oral GLP‑1 receptor agonist for chronic weight management – a historic first for an anti‑obesity pill. The approval offers patients a non‑injectable alternative, potentially transforming obesity care in a market hungry for innovation.
FDA Approved Rucaparib for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
oncodaily - On December 17, 2025, the FDA issued a regular approval for rucaparib (Rubraca®), marking the formal conversion of its earlier accelerated authorization into full approval for BRCA-mutated metastatic castration-resistant prostate […]
AI Summary: The FDA has granted full approval to rucaparib (Rubraca®) for treating adults with BRCA‐mutated metastatic castration‐resistant prostate cancer, converting its prior accelerated approval into standard approval. This landmark decision offers a new treatment option for patients with this genetic profile.
FDA Removes Key Limitation on the Use of Real-World Evidence in Regulatory Reviews
oncodaily - On December 15, 2025, the U.S. Food and Drug Administration (FDA) announced a significant update to its regulatory approach regarding the use of real-world evidence (RWE) in drug and medical […]
AI Summary: The FDA has dramatically loosened its long‐standing limitations on the use of real‐world evidence in regulatory reviews, signaling an era where big data may facilitate quicker approvals for innovative drugs. Officials are also urging early-phase trials reform to better capture real‐world outcomes.
Optum Rx: 100% of network community pharmacies shift to cost-based model
fiercehealthcare - Earlier this year, Optum Rx announced that it would shift to a cost-based model, which would boost reimbursements for brand-name drugs at community pharmacies.
AI Summary: In a significant payment model overhaul, Optum Rx has moved 100% of its community and independent pharmacies to a cost‐based model, a change aimed at aligning reimbursements with actual expenses and enhancing pharmacy viability in a challenging market.
Carolyn Bertozzi Returns to Eli Lilly and Company Board of Directors 2025
oncodaily - Eli Lilly and Company has announced the election of Carolyn R. Bertozzi, Ph.D., as a returning member of its Board of Directors, effective December 8, 2025. In her renewed role, […]
AI Summary: Eli Lilly has announced the return of renowned scientist Carolyn Bertozzi to its Board of Directors. Her comeback underscores the company’s commitment to a research‐intensive strategy and reinforces its focus on cutting–edge oncology and other therapeutic innovations.
FDA approves 1st gene therapy for Wiskott-Aldrich syndrome
Ella Jeffries / beckershospitalreview - The FDA has approved Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome, a rare and life-threatening immune disorder. Waskyra is indicated for pediatric patients 6 months and older, as well as adults with Wiskott-Aldri…
AI Summary: In a landmark decision, the FDA approved Waskyra – the first gene therapy for Wiskott‐Aldrich syndrome – offering new hope for patients with this rare and life‐threatening immune disorder. The agency’s flexible approach in handling rare disease treatments marks a turning point in precision medicine.
Zoliflodacin shows promise as single-dose treatment for gonorrhea
A Phase III trial has demonstrated that zoliflodacin – a single-dose oral antibiotic – is highly effective against drug‐resistant gonorrhea, offering an innovative solution to a mounting public health threat. The encouraging results suggest a potential game‐changer in the fight against antibiotic-resistant infections.
Adding Tucatinib to First-line Maintenance Therapy Delayed Disease Progression in HER2-positive Metastatic Breast Cancer in HER2CLIMB-05 Trial
Kathleen Medora / aacr - Benefit was seen across all subgroups, including in patients with brain metastasis SAN ANTONIO – Adding tucatinib (Tukysa) to first-line maintenance therapy with trastuzumab (Herceptin) and pertuzumab (Perjeta) delayed disease progression in patients with…
AI Summary: A phase III trial—part of the HER2CLIMB-05 study—showed that adding tucatinib to first‑line maintenance therapy with trastuzumab and pertuzumab significantly delayed disease progression in patients with HER2‑positive metastatic breast cancer, with benefits observed across key subgroups including those with brain metastases.
Sacituzumab govitecan-hziy led to similar progression-free survival as standard of care for some breast cancers: Trial
medicalxpress - Patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancers had similar progression-free survival (PFS) whether they were treated with sacituzumab govitecan-hziy (Trodelvy) or standard-of-care chemotherapy as the first treatment af…
AI Summary: Trial results indicate that patients with HR‑positive, HER2‑negative advanced breast cancers treated with sacituzumab govitecan‑hziy experienced similar progression‑free survival to those receiving standard care. Two reports from the same trial underlined these findings, reinforcing the therapy’s potential for endocrine therapy‑refractory tumors.
Novel Endocrine Therapy Giredestrant Improves Disease-free Survival Over Standard of Care for Patients With Early-stage Breast Cancer in Phase III lidERA Trial
Kathleen Medora / aacr - SAN ANTONIO – The investigational, oral selective estrogen receptor degrader (SERD) giredestrant given as an adjuvant therapy showed significant improvement in invasive disease-free survival (iDFS) compared with the current standard-of-care endocrine ther…
AI Summary: An international Phase III trial led by UCLA reveals that giredestrant, a novel endocrine therapy, significantly reduces recurrence risk in early‐stage breast cancer compared with standard care. The robust findings promise to shift hormonal treatment paradigms—even if skeptics may raise a wry eyebrow at yet “another” incremental advance in a crowded field.
CVS Health agrees to pay $37.8M to settle fraud allegations over insulin pens
fiercehealthcare - CVS Health agreed to pay $37.76 million to settle allegations that it dispensed too many insulin pens to patients and improperly billed federal healthcare programs for those prescriptions.
AI Summary: CVS Health has agreed to pay approximately $38 million to settle allegations that it improperly dispensed insulin pens and misbilled federal health programs, resolving accusations of fraudulent practices and restoring trust in its operations.