Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.

UCB and Zogenix have agreed to an acquisition deal totaling nearly $2 billion.

Merck and Ridgeback Therapeutics will supply UNICEF with up to three million capsules of molnupiravir through the first half of 2022.

A report by international regulators reviews the effectiveness of current COVID-19 vaccines against the omicron variant.

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.

AstraZeneca's Tagrisso has been accepted for use as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations in Scotland.

Air France KLM Martinair Cargo and Envirotainer are collaborating on more sustainable air transport of pharmaceuticals

PharmaLex Group has merged with MAP Group, broadening its market access expertise and extending its reach into the Italian marketplace.

Cyxone has appointed a European CDMO to scale-up and produce the active ingredient of its T20K drug candidate.

The company is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups because of microbial contamination.

The agency discusses its response to COVID-19 and other milestones in its year-end review.

The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.

In their collaboration, Bristol Myers Squibb and Prellis Biologics aim to generate human antibody libraries for select targets to enable drug discovery.

After a previously announced merger, Protagen Protein Services, BioAnalytix, and GeneWerk have formed a new CRO under the name ProtaGene.

Protective external packaging ensures COVID-19 vaccines arrive safely.

Pfizer will pay Beam $300 million upfront to conduct research on three undisclosed base editing targets in the liver, muscle, and central nervous system.

CDMO Forge Biologics will accelerate its manufacturing capacity expansion using an additional $80 million in funding it recently secured.

Fosun Pharma and Insilico Medicine will collaborate on AI-driven drug discovery and development of product candidates targeting multiple disease targets.

According to the company, Lumykras (Sotorasib) is the first targeted therapy approved in the European Union for patients with the KRAS G12C mutation.

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

The collaboration between Bristol Myers Squibb and Century Therapeutics will combine Century’s iPSC-derived allogeneic cell therapy platform with Bristol Myers Squibb’s expertise in cell therapy and oncology drug development.

Fujifilm Diosynth Biotechnologies' 89,000 square-foot expansion of its BioProcess Innovation Center in Research Triangle Park, N.C., will double its capacity to support process characterization.

The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).

The agreeement will add to Merck KGaA’s LNP and mRNA capabilities.

The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.

Bio-Rad’s new assays are designed to measure neutralizing antibodies against wild-type and significant variants of COVID-19.

FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

The collaboration will leverage Alynlam’s proprietary small interfering RNA (siRNA) technology to inhibit a target discovered by Novartis.