
GSK seeks FDA approval for Leucovorin to treat cerebral folate deficiency and autism symptoms, promising new hope for affected children.
GSK seeks FDA approval for Leucovorin to treat cerebral folate deficiency and autism symptoms, promising new hope for affected children.
Scholar Rock navigates FDA's Complete Response Letter for Apitegromab, aiming for swift resubmission to address spinal muscular atrophy treatment needs.
The President announced FDA will no longer recommend the use of the common painkiller during pregnancy, despite a casual link between the medication and autism not being established.
In today’s Pharmaceutical Executive Daily, we cover Biogen’s acquisition of Alcyone Therapeutics to expand its drug delivery solutions, the FDA’s expanded approval of Incyte’s Opzelura for atopic dermatitis in young children, and Pfizer’s move to acquire Metsera to strengthen its obesity and cardiovascular pipeline.
FDA denies approval for Rexulti in PTSD treatment, citing insufficient evidence despite clinical trials. Otsuka and Lundbeck plan next steps.
Pfizer acquires Metsera for $4.9 billion, enhancing its portfolio in obesity and cardiovascular treatments with innovative therapies and strong clinical potential.
In today’s Pharmaceutical Executive Daily, we cover how pharma companies can scale AI pilots into enterprise-wide value, GSK’s plan to invest $30 billion in U.S. biopharma capacity, and Novo Nordisk’s clinical trial success with oral Wegovy.
CDC vaccine advisers delay Hepatitis B schedule changes while recommending separate vaccines for measles, mumps, rubella, and chickenpox amid safety concerns.
Biogen expands its drug delivery solutions by acquiring Alcyone Therapeutics, enhancing patient-centered therapies with the innovative ThecaFlex DRx system.
VectorY Therapeutics partners with Shape Therapeutics to advance innovative therapies for neurodegenerative diseases using SHP-DB1 technology and AAV5 capsids.
The FDA has expanded the indication of Incyte’s Opzelura (ruxolitinib) cream to include children aged two to 11 years with mild to moderate atopic dermatitis, making it the first steroid-free topical treatment option for this age group.
In today’s Pharmaceutical Executive Daily, we explore how AI is disrupting higher education and career pathways, AllRock Bio’s $50 million Series A funding to advance its lead molecule, and FDA warning letters issued to Novo Nordisk, Eli Lilly, and Hims over misleading drug advertising.
Former CDC director Susan Monarez raises alarms about potential changes to childhood vaccine schedules, warning of increased health risks for children.
Novo Nordisk's shares rise as Phase III trial shows its oral Wegovy pill achieves significant weight loss, offering a new option for patients.
The company announced the plans as President visited the UK.
Roche strengthens its pipeline by acquiring 89bio and its promising MASH treatment, Pegozafermin, enhancing options for metabolic disease therapies.
In today’s Pharmaceutical Executive Daily, we cover Lilly’s orforglipron as a prime candidate for FDA fast-track approval, Merck and Daiichi Sankyo’s breakthrough therapy designation for R-DXd in ovarian cancer, and Novo Nordisk’s EU approval of Rybelsus for reducing cardiovascular risk.
FDA warns major pharmaceutical companies to improve transparency in drug advertising, addressing misleading claims and enforcing stricter regulations.
VarmX partners with CSL to advance VMX-C001, a groundbreaking treatment for patients on FXa DOACs, enhancing surgical outcomes and patient care.
Eli Lilly's Orforglipron shows superior results in glycemic control and weight loss compared to oral semaglutide in recent clinical trials.
The new Goochland County facility will serve as Lilly’s first fully integrated API and drug product site, focusing on antibody-drug conjugates, while creating thousands of jobs and strengthening domestic supply chains.
A Harvard Business School Healthcare Alumni Q&A with Professor Eric Mazur of Harvard University.
In today’s Pharmaceutical Executive Daily, we cover AbbVie’s stock jump following a Rinvoq litigation settlement, new insights into the ROI of specialty pharmacy adherence programs, and a closer look at what true innovation in PBM management entails.
AllRock Bio secures $50 million to advance Roc-101, a promising treatment for pulmonary hypertension, aiming to transform patient care.
The new members include individuals who have ties to fringe medical communities.
Novo Nordisk's Rybelsus gains EU approval for cardiovascular benefits, enhancing treatment options for type 2 diabetes and improving patient outcomes.
R-DXd has previously shown promising clinical results in platinum-resistant ovarian, peritoneal, and fallopian tube cancers.
Eli Lilly's Orforglipron may become the first drug fast-tracked under the FDA's new program, promising quicker access for weight loss treatment.
Updates to its policies have made FDA’s CRLs a key talking point.
In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s return-to-office mandate from its CEO, the evolving COVID-19 vaccine landscape in 2025, and Capsida’s decision to halt a gene therapy trial following a patient death.