The discussion at Thursday’s FDA advisory committee meeting on a COVID-19 vaccine from Moderna and NIH highlighted the increasing difficulties of conducting trials as more vaccines become authorized and...

FDA’s first authorization of an over-the-counter, at-home COVID-19 antigen test marks a major step in the intersection of individual self-monitoring and public health, and ups the ante on communicating uncertainty around results.  Abbott’s home test,...

The few points of concern raised at the advisory committee meeting for Pfizer-BioNTech’s COVID-19 vaccine likely won't be issues for Moderna’s candidate. Briefing documents released ahead of Thursday...

Among the many properties of Humira, one of the most surprising is its use as a probe to uncover a seemingly endless series of legal and regulatory maneuvers that allow its manufacturer, AbbVie, to maintain...

By moving up BNT162b2’s review by its drugs authorization committee to Dec. 21, EMA has opened the door for the COVID-19 vaccine from Pfizer and BioNTech to be approved in the EU by year-end. If CHMP recommends...

The migration of new modalities into prevalent indications took another step forward on Friday with the European Commission’s approval of Novartis’ siRNA therapy Leqvio inclisiran to treat hypercholesterolemia...

In a decision that marks a turning point in the most ambitious effort to apply science and technology to defeat an existential threat since World War II, FDA has joined regulatory agencies from the U.K....

Documents suggest FDA panel could smile on Entresto label expansionIn briefing documents released ahead of FDA’s advisory committee meeting to review an NDA for Entresto sacubitril/valsartan from Novartis AG (NYSE:NVS; SIX:NOVN), the agency said overall benefit-risk...

In its December opinions, EMA’s CHMP recommended a restriction for Gilead’s Veklury, specifying that COVID-19 patients should be on low- or high-flow oxygen or other non-invasive ventilation at the start of treatment.  The committee also...

The U.K. will start its COVID-19 vaccination program next week following MHRA’s authorization of BNT162b2 from partners BioNTech and Pfizer. The news comes as some European lawmakers criticized the speed of MHRA’s approval. It’s the first authorization...

Blueprint gains broader FDA label for Gavreto FDA approved Gavreto pralsetinib from Blueprint Medicines Corp. (NASDA:BLUE) to treat advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive, radioactive iodine-refractory thyroid cancer in patients at...

With the approval of Oxlumo to treat primary hyperoxaluria, Alnylam is aiming to accelerate patient access to the ultra-rare disease therapy by building on the performance- and prevalence-based pricing...

FDA on Wednesday made public the review that led to approval of Gilead’s Veklury remdesivir for treatment of hospitalized COVID-19 patients, and explained why it believes the WHO-sponsored SOLIDARITY trial that failed to demonstrate a...

Starting Tuesday, distribution of Regeneron’s antibody cocktail for COVID-19 will begin via an existing network of hospitals and associated facilities, with plans for a subsequent expansion that will include a broader range of outpatient centers....

EC approves Alnylam, Alexion therapiesAlnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said the European Commission approved Oxlumo lumasiran, an RNAi therapy targeting the HAO1 mRNA that encodes glycolate oxidase, to treat primary hyperoxaluria in all age groups. The...