FDA approves new meds from KalVista, Dizal

Today’s Big News

Jul 7, 2025

CSL trims R&D team, shifts focus toward external opportunities


Baxter taps a new CEO as it emerges from years-long restructuring


KalVista bounces back from FDA delay with approval for oral rare disease med Ekterly


Dizal to challenge J&J with FDA approval for lung cancer drug Zegfrovy


Provider groups sue RFK Jr. to roll back COVID-19 vaccine recommendation changes


Novo’s Wegovy retakes top TV spending spot in June, edging out AbbVie, J&J immunology ads


Amid $15B AstraZeneca partnership rumor, Summit needs $7.7B upfront to excite investors: analyst

 

Featured

CSL trims R&D team, shifts focus toward external opportunities

CSL is consolidating its R&D team in an effort to better position the organization “for long-term success in a rapidly evolving global environment.”
 

Top Stories

Baxter taps a new CEO as it emerges from years-long restructuring

Andrew Hider will join the medtech after about eight years of leading ATS, a provider of factory automation solutions across multiple industries, including the life sciences.

KalVista bounces back from FDA delay with approval for oral rare disease med Ekterly

The FDA has approved sebetralstat under the brand name Ekterly as a new, oral treatment option for acute attacks of hereditary angioedema (HAE) in adults and children ages 12 years and older. The nod came just a few short weeks after the agency missed its June 17 target date originally established for the decision.

Dizal to challenge J&J with FDA approval for lung cancer drug Zegfrovy

China's Dizal Pharmaceuticals has gained its first FDA approval, winning an accelerated nod for Zegfrovy to become the only U.S.-endorsed oral treatment for those with a rare type of non-small cell lung cancer.

Provider groups sue RFK Jr. to roll back COVID-19 vaccine recommendation changes

The lawsuit brought by the American Academy of Pediatrics, the Infectious Diseases Society of America and others seeks relief on COVID-19 vaccine recommendations for pregnant women and youth, but calls attention to the secretary's other controversial actions on vaccines.

Novo’s Wegovy retakes top TV spending spot in June, edging out AbbVie, J&J immunology ads

As summer began and temperatures rose in June, so too did TV ad spending for Novo Nordisk’s Wegovy.

Amid $15B AstraZeneca partnership rumor, Summit needs $7.7B upfront to excite investors: analyst

After several PD-1xVEGF competitors forged alliances with Big Pharma players, Summit Therapeutics, the frontrunner in this hot cancer drug field, is reportedly seeking its own deal.

Roche’s Chugai inks $250M Gero deal to access age-related disease targets

Chugai Pharmaceutical has teamed up with Gero, offering up to $250 million for the chance to develop antibodies against age-related disease targets identified by its partner's AI-driven platform.

Boston Scientific expands Farapulse’s reach in afib with new FDA approval

In its first year on the market, Farapulse brought in more than $1 billion in revenue. Now Boston Scientific aims to double its reach to the full afib population.

Jasper warns of restructuring after dud batch of urticaria drug derails trials, sinking stock

Jasper Therapeutics is blaming a dud batch of its urticaria drug for derailing a phase 1/2 study of the candidate and raising the possibility of a restructuring to conserve cash.

Cell therapy biotech shares first clinical data for in vivo CAR-T that attracted $1B AstraZeneca acquisition

Months after announcing an M&A deal with AstraZeneca, EsoBiotec has released the first small slice of data on the cell therapy asset that attracted the Big Pharma’s attention. Four patients with multiple myeloma who received the Belgian biotech’s in vivo T-cell editing therapy all responded to treatment, with the cancer of two patients resolving completely.

HIV drugmaker Theratechnologies agrees to $254M buyout by CDMO Future Pak

Future Pak's most recent bid for Theratechnologies won over the HIV drugmaker's board and a special sale committee. The CDMO has been chasing a Theratechnologies buyout since at least August of last year.

FDA clears Fasikl's AI neurostimulation wristwatch for essential tremor

The company’s Felix NeuroAI Wristband aims to provide personalized stimulation therapy based on real-time feedback to help interrupt the involuntary shaking that can occur in the hands.
 
Fierce podcasts

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Teva’s CEO shares ‘Pivot to Growth’ progress

In this episode of "The Top Line," Teva CEO Richard Francis shares progress on the company’s “Pivot to Growth” strategy and what lies ahead.
 

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How Will US Policy Impact the Growth of UK Biotech?

Presented by Blue Matter, strategic consultants in the life sciences
 

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