Novo Nordisk’s Wegovy Pill Becomes First FDA-Approved Oral GLP-1 Drug for Weight Loss / MedCity
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.…
#obesity #healthcare #pharmaceuticals #novonordisk #weightloss #drugdevelopment #fda
Tuesday, December 23, 2025, 3:22 pm / permalink 17254 / 36 stories in 2 months
FDA Approved Rucaparib for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer / OncoDaily
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 […]
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Saturday, December 20, 2025, 9:20 pm / permalink 17185 / 13 stories in 2 months
FDA Removes Key Limitation on the Use of Real-World Evidence in Regulatory Reviews / OncoDaily
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 […]
#healthcare #pharmaceuticals #publichealth #governmentpolicy #drugdevelopment #fda
Saturday, December 20, 2025, 4:21 pm / permalink 17179 / 13 stories in 2 months
Carolyn Bertozzi Returns to Eli Lilly and Company Board of Directors 2025 / OncoDaily
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, […]
#healthcare #pharmaceuticals #elililly #biotech #drugdevelopment
Monday, December 15, 2025, 4:22 am / permalink 16960 / 2 stories in 2 months
FDA approves 1st gene therapy for Wiskott-Aldrich syndrome / Beckers
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…
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Monday, December 15, 2025, 2:21 am / permalink 16954 / 4 stories in 2 months
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.
#healthcare #pharmaceuticals #publichealth #drugdevelopment
Saturday, December 13, 2025, 8:21 pm / permalink 16937 / 2 stories in 2 months
Adding Tucatinib to First-line Maintenance Therapy Delayed Disease Progression in HER2-positive Metastatic Breast Cancer in HER2CLIMB-05 Trial / American Association for Cancer Research
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…
#healthcare #pharmaceuticals #drugdevelopment
Saturday, December 13, 2025, 4:21 am / permalink 16917 / 6 stories in 2 months
Sacituzumab govitecan-hziy led to similar progression-free survival as standard of care for some breast cancers: Trial / Medical Express
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…
#healthcare #pharmaceuticals #drugdevelopment
Saturday, December 13, 2025, 1:21 am / permalink 16912 / 5 stories in 2 months
Novel Endocrine Therapy Giredestrant Improves Disease-free Survival Over Standard of Care for Patients With Early-stage Breast Cancer in Phase III lidERA Trial / American Association for Cancer Research
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…
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment
Wednesday, December 10, 2025, 11:22 am / permalink 16789 / 15 stories in 3 months
Startup Protego Bio Lands $130M for First-in-Class Drug’s Pivotal Test in Rare Plasma Disorder / MedCity
Frank Vinluan / medcitynews - Protego Biopharma’s lead program is a potential treatment for the rare disease light chain amyloidosis. The startup says the novel mechanism of its oral small molecule should have better outcomes than antibodies from AstraZeneca and Prothena that failed t…
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment
Saturday, December 6, 2025, 10:21 am / permalink 16661 / 2 stories in 3 months
A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes / Fierce
fiercehealthcare - Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.
#healthcare #publichealth #governmentpolicy #biotech #drugdevelopment #fda #vaccinesafety
Thursday, December 4, 2025, 10:23 am / permalink 16565 / 10 stories in 3 months
FDA approves all ages gene therapy for spinal condition / Beckers
Ella Jeffries / beckershospitalreview - The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and adults. The therapy is designed to address the genetic …
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Monday, December 1, 2025, 4:21 am / permalink 16428 / 2 stories in 3 months
Novo submits high-dose Wegovy for FDA approval using voucher / Endpoints
Max Bayer / endpoints - Novo Nordisk submitted a higher dose of its obesity drug Wegovy for FDA approval and is using a recently-won voucher to expedite the review. The company said Wednesday that it submitted ...
#obesity #healthcare #pharmaceuticals #novonordisk #weightloss #publichealth #biotech #drugdevelopment #fda
Saturday, November 29, 2025, 5:21 pm / permalink 16400 / 2 stories in 3 months
CASSANDRA-PACT-21 Trial Update: Preoperative PAXG vs mFOLFIRINOX in Resectable and Borderline Resectable PDAC / OncoDaily
oncodaily - The landscape of early-stage pancreatic ductal adenocarcinoma (PDAC) continues to evolve as clinicians move from surgery-first strategies toward perioperative treatment. Neoadjuvant and perioperative approaches have shown growing promise, yet no […]
#healthcare #pharmaceuticals #publichealth #drugdevelopment
Saturday, November 29, 2025, 9:21 am / permalink 16387 / 5 stories in 3 months
Novo Nordisk GLP-1 fails to slow Alzheimer’s in trials / Beckers
Ella Jeffries / beckershospitalreview - Novo Nordisk’s GLP-1 drug semaglutide did not demonstrate a statistically significant effect in slowing progression of Alzheimer’s disease in two late-stage clinical trials. According to a Nov. 24 news release from the company, two double-blinded, placebo…
#obesity #healthcare #pharmaceuticals #novonordisk #weightloss #publichealth #biotech #drugdevelopment
Tuesday, November 25, 2025, 10:21 am / permalink 16294 / 5 stories in 3 months
FDA Approves Pembrolizumab + Enfortumab Vedotin-ejfv for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer / OncoDaily
oncodaily - What Does FDA Approval Mean? The U.S. Food and Drug Administration (FDA) evaluates new cancer therapies to determine whether they are safe and effective for clinical use. Approval is based […]
#healthcare #pharmaceuticals #publichealth #drugdevelopment #fda
Monday, November 24, 2025, 10:23 am / permalink 16257 / 2 stories in 3 months
New nasal nanodrops wipe out brain tumors in mice / Science Daily Cancer
sciencedaily - A new nasal-delivered nanotherapy shows promise against aggressive glioblastoma tumors. By activating the STING immune pathway using gold-core spherical nucleic acids, researchers were able to reach the brain without invasive surgery. When paired with dru…
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment
Saturday, November 22, 2025, 1:21 pm / permalink 16217 / 3 stories in 3 months
FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukaemia with a NPM1 Mutation / ESMO
esmo - Evidence for efficacy is based on the results from the KO-MEN-001 study
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Saturday, November 22, 2025, 9:22 am / permalink 16210 / 2 stories in 3 months
Mikael Dolsten removes himself from board candidacy at Novo; Bavarian Nordic chairman resigns / Endpoints
Alex Hoffman / endpoints - → In what appears to be another blow to Novo Nordisk, ex-Pfizer CSO Mikael Dolsten has withdrawn his nomination to join the company's board of directors due to ...
#healthcare #pharmaceuticals #publichealth #biotech #mergersandacquisitions #corporatetakeover #drugdevelopment
Saturday, November 15, 2025, 3:21 pm / permalink 16003 / 2 stories in 3 months
FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths / ABC News
go - The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Saturday, November 15, 2025, 5:21 am / permalink 15991 / 3 stories in 3 months