US FDA's Slim October User Fee Calendar Brings Some Controversy

US FDA's Slim October User Fee Calendar Brings Some Controversy

 

Advisory committee concerns cast clouds over Iterum’s oral antibiotic, Intercept’s Ocaliva, and perioperative immuno-oncology regimens, while CSL and Pfizer aim to take their hematology franchises in new directions.

Evergreen With Envy: Halozyme’s Subcutaneous Conversions Grow As Rivals Hope To Break In

Evergreen With Envy: Halozyme’s Subcutaneous Conversions Grow As Rivals Hope To Break In

 

Halozyme’s Enhanze technology has now brought seven monoclonal antibodies, including Ocrevus and Tecentriq, from IV to subcutaneous delivery, but Alteogen and other high-concentration formulation players hope to join the party as Medicare pricing issues help drive interest.

US FDA September User Fee Calendar Slims Down, Still Boasts More Than Five Novel Agents

US FDA September User Fee Calendar Slims Down, Still Boasts More Than Five Novel Agents

 

New therapies in the wings include two candidates for Niemman-Pick disease type C, a first-in-class antipsychotic, a targeted oncology therapy under Real-Time Oncology Review, and a new drug for gastroparesis.

Slow Burn: US FDA RMAT Designations Surge While Breakthrough Pace Softens

Slow Burn: US FDA RMAT Designations Surge While Breakthrough Pace Softens

 

The US FDA’s regenerative medicine advanced therapy designation is seeing its biggest year yet after a slower ramp-up than the more established breakthrough therapy pathway.


Dozen Novel Agents Dream Of August US FDA Approval

Dozen Novel Agents Dream Of August US FDA Approval

 

A stacked user fee goal lineup sets the stage for market showdowns in primary biliary cholangitis and IgA nephropathy, the first psychedelic approval decision, and lots of targeted cancer therapies.

Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU

Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU

 
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Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.

Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar

Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar

 

Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.

US FDA Calls ’Em Like Its Advisory Committees See Them

US FDA Calls ’Em Like Its Advisory Committees See Them

 

So far this year, when the agency has taken action on NMEs that went before advisory committees, the FDA decision has matched the committee vote.


Coming Attractions: Novel Agents In Line For US FDA Decisions By Year-End

Coming Attractions: Novel Agents In Line For US FDA Decisions By Year-End

 

Interactive table from the Pink Sheet breaks down the 40 novel drugs and biologics have user fee goal dates before the new year.

Steady On For US FDA’s Novel Approvals At Mid-Year, But Another 2023 Is Unlikely

Steady On For US FDA’s Novel Approvals At Mid-Year, But Another 2023 Is Unlikely

 

US FDA would need to approve 44 novel agents by year-end to match 2023’s big total, but only 40 candidates are known to have user fee goals in the second half of 2024.

Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications

Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications

 

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.

US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals

US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals

 

Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.