BioPharma Dive - Latest News

FDA meeting on flu vaccine composition is canceled

The meeting, which helps the FDA give guidance to vaccine makers on which flu st...

Vertex ends gene editing research pact with Verve

Verve offered few details on the early end of a collaboration the companies inke...

Lilly CEO wields manufacturing plans to push pharma-fri...

While announcing billions of dollars in new U.S. investments, company chief Davi...

AstraZeneca’s next breast cancer drug; Madrigal’s accel...

The British drugmaker claimed study success in a first-line setting in breast ca...

Lilly expands US manufacturing build-out with $50B target

The company is doubling plans for capital spending on U.S. factories as Presiden...

Eikon raises $351M in one of the year’s largest biotech...

The funding comes as Eikon, run by former Merck research chief Roger Perlmutter,...

Drug compounders sue FDA over declaration ending Wegovy...

Telehealth provider Hims & Hers said it will tell consumers they need to seek “a...

Regeneron gene therapy helps deaf children hear in smal...

Ten of 11 children born with a rare form of congenital hearing loss experienced ...

‘Fear and uncertainty’: Biotech investors warn of impac...

The Trump administration’s plans to reduce National Institutes of Health grant f...

FDA brings back some fired device office staff

An industry source said “most, if not all” of the people at CDRH who were recent...

Summit partners with Pfizer to study bispecific, ADC co...

The partners will test Summit’s ivonescimab alongside Pfizer’s antibody-drug con...

Mirum drug for rare genetic disease gains FDA approval

Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendi...

Pfizer names Patrizia Cavazzoni, former top FDA officia...

Cavazzoni stepped down from her role as head of the FDA’s main drug review offic...

Sanofi, Teva add to case for new bowel disease drug

Detailed results presented at a medical congress help reinforce analyst expectat...

Partnering for success in early phase clinical development

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve ...

Ozempic, Wegovy shortage resolved; Pfizer CEO is PhRMA’...

The FDA determined that Novo Nordisk’s obesity and diabetes drugs were no longer...

Pfizer stops selling hemophilia gene therapy, citing we...

Pfizer’s decision to halt further marketing of Beqvez is further sign of the spa...

Bluebird, at risk of default, agrees to take-private deal

The pioneering gene therapy developer will be acquired by investment firms Carly...

CDC vaccine meeting, set to be first since RFK Jr. swor...

Originally scheduled for next week, the meeting of agency advisers will be delay...

Device industry scrambles amid concern FDA layoffs will...

Layoffs at the FDA’s device center could add “months, if not years” to the time ...

In FDA job cuts, experts see threat of far-reaching impact

"Any place that gets cut, it's going to have an impact, because there's not any ...

Advamed CEO warns FDA cuts put patients, industry at risk

Scott Whitaker sent a letter to HHS calling for staff cuts at the FDA to be reve...

FTC case against PBMs can move forward, judge rules

A Missouri district court judge said stopping the FTC’s suit against Caremark, E...

AstraZeneca deepens China presence with FibroGen deal

The $160 million acquisition of a FibroGen subsidiary expands AstraZeneca’s foot...

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