Approval of Onyda XR marks the first liquid non-stimulant medication for attention-deficit hyperactivity disorder to hit the market in the United States.

Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.

Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer.

Multiple surveys show that older voters are concerned about the cost of healthcare and Medicare, along with other financial concerns.

The company will present research from multiple projects completed in collaboration with multiple partners.

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Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma.

Priority Review status for inavolisib is based on positive Phase III data showing the inavolisib-based regimen significantly extended progression-free survival in patients with hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvosoltamab, Regeneron talks key findings from the ongoing phase I/II trial of linvoseltamab in multiple myeloma that led to the submission of an FDA Biologics License Application (BLA).

The company will offer clients access to spectral data files.

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The Statistical Computing Environment Coalition aims to improve data flow and gets drugs approved more quickly.

The acquisition of a novel therapy for atopic dermatitis includes an all-cash transaction totaling approximately $1.25 billion.

Fast track designation for AV-001 comes amid promising results from a Phase I trial, which supported once-daily dosing and effective Tie2 activation.

Slack, CEO and chairman for START Center for Cancer Research, discusses the complications that patients have getting enrolled in clinical trials.

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The CEO of AION Labs discusses both the new ways that AI is being implemented in drug development and why Israel is becoming the center of AI development in the pharma industry.

The company is collaborating with CPESN USA to bring more services to customers at independent pharmacies across the country.

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Joint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders.

Cityblock is partnering with Sunshine Health in Florida.

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Approval for the Phase III protocol of LAE002 Plus LAE001 come as a result of posiive Phase II data, which showed promising benefits for metastatic castration-resistant prostate cancer (mCRPC) patients.

Under terms of the agreement, Nona Biosciences is expected to receive an upfront payment of $19 million, with the potential of up to $585 million in milestones.

Cencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges.