All News

Bristol Myers Squibb acquires Orbital Therapeutics to enhance its CAR T-cell therapy portfolio, promising innovative treatments for autoimmune diseases.

Shana Tetrault, PhD, Director of Product Marketing at Quanterix, outlined strategies for integrating blood-based biomarkers into routine clinical care pathways, ensuring minimal disruption for patients and clinicians.

Regeneron's Libtayo gains FDA approval as the first immunotherapy for high-risk cutaneous squamous cell carcinoma, enhancing patient treatment options.

Novo Nordisk acquires Akero Therapeutics to enhance its portfolio with efruxifermin, a promising treatment for metabolic dysfunction-associated steatohepatitis.

Shana Tetrault, PhD, Director of Product Marketing at Quanterix, discussed challenges in positioning Simoa in the precision health market, stressing its accuracy and reliability in diverse populations.

In today’s Pharmaceutical Executive Daily, we explore why medical AI success depends on more than algorithms, Amgen’s launch of its new direct-to-consumer platform AmgenNow, and AstraZeneca’s multi-target research partnership with Algen.

FDA approves Jascayd, the first new treatment for idiopathic pulmonary fibrosis in over a decade, significantly reducing mortality risk for patients.

Johnson & Johnson's Simponi gains FDA approval for treating pediatric ulcerative colitis, expanding options for young patients with this chronic condition.

Shana Tetrault, PhD, Director of Product Marketing at Quanterix, discussed translating complex scientific findings into actionable insights for healthcare providers and stakeholders, emphasizing the importance of early disease detection.

Algen Biotechnologies partners with AstraZeneca to enhance AI-driven drug discovery, targeting chronic inflammatory conditions for innovative therapeutic solutions.

Chiesi Group partners with Arbor Biotechnologies to advance gene editing therapies for rare diseases, focusing on primary hyperoxaluria type 1.

Amgen introduces AmgenNow, a direct-to-patient program for Repatha, offering affordable access to life-saving cardiovascular treatment.

Stay informed on key pharmaceutical news, including FDA insights, Takeda's strategic shifts, and updated CDC COVID-19 vaccination guidelines.

CDC introduces shared-decision making for COVID-19 vaccinations, emphasizing informed consent and individual consultation with healthcare providers.

Neurizon Therapeutics advances ALS treatment as FDA lifts clinical hold on NUZ-001, paving the way for Phase II and III trials.

Dr. Jeanne Marrazzo's firing highlights concerns over political interference in health research and vaccine safety advocacy amid whistleblower allegations.

In today’s Pharmaceutical Executive Daily, we cover the FDA’s new fast-track review program for U.S.-made generics, Novartis’ FDA approval of Rhapsido for chronic spontaneous urticaria, and Halozyme’s $750 million acquisition of Elektrofi to strengthen drug delivery innovation.

Products tested and manufactured exclusively from domestic materials will be eligible for the program.

Roche's Tecentriq and lurbinectedin combo gains FDA approval, significantly improving outcomes for extensive-stage small cell lung cancer patients.

Jazz Pharmaceuticals announces FDA approval of Zepzelca and Atezolizumab for extensive-stage small cell lung cancer, enhancing treatment options and survival rates.

Stay informed on key pharmaceutical news, including tariff updates, FDA shutdown risks, and insights from recent cell and gene therapy reviews.

Takeda shifts focus from cell therapy to innovative drug candidates, aiming for transformative therapies and strategic partnerships in its pipeline.

Vanda Pharmaceuticals collaborates with the FDA to expedite reviews for Hetlioz and Tradipitant, aiming to resolve ongoing disputes and approvals.

FDA continues essential operations during the funding lapse, focusing on public health safety while halting new drug applications and submissions.

This marks the latest change in the President’s strategy.

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s resubmission of its BLA for Awiqli, the FDA’s approval of Kedrion’s Qivigy for primary humoral immunodeficiency, and Eli Lilly’s decision to halt development of a muscle-preserving weight-loss therapy.

Novartis gains FDA approval for Rhapsido, the first oral BTK inhibitor for Chronic Spontaneous Urticaria, offering new hope for patients.