The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.

Organizations can better understand the maturity of AI-driven automation technology across their organization’s IT landscape through effective pharmacovigilance.

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.

FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.

FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.

Sumitovant Bipharma has completed its acquisition of Myovant Sciences for approximately $1.7 billion.

Silicon Valley Bank has collapsed, leaving many biotechnology companies unsure of the future.

Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.

Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.

Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.

Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.

Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.

Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.

EnteroBiotix is harnessing the power of the microbiome to target an array of diseases.

PAT is crucial to process control and real-time release in continuous manufacturing of solid-dosage drugs.

Technological advances will help ease pressure on pharma supply chains, allowing for greater visibility and less uncertainty.

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

Soaring energy costs are compounding the challenges currently being faced by the European bio/pharma industry.

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

AstraZeneca has entered into a global exclusive license agreement with KYM Biosciences for CMG901, which is being investigated as a gastric cancer treatment.

CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

WHO is appealing for US $392 million to reach 12.9 million people with essential health assistance in 2023.

Orchard Therapeutics has announced an agreement which will enable reimbursed access to Libmeldy for all eligible MLD patients in Sweden.