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Pharmaceutical Industry News

Regeneron is taking a simplified…

December 4th, 2025|Fierce Pharma|

Regeneron is taking a simplified approach in its bid to move T-cell engagers Lynozyfic and Ordspono into earlier lines of blood cancer treatment by trying to offer less onerous regimens for patients.

The latest untitled letter from…

December 4th, 2025|Fierce Pharma|

The latest untitled letter from the FDA’s Office of Prescription Drug Promotion zeroes in on a patient testimonial video about Daiichi Sankyo’s tenosynovial giant cell tumor treatment Turalio.

Theresa Michele, the director of…

December 4th, 2025|Fierce Pharma|

Theresa Michele, the director of the Office of Nonprescription Drugs for a decade, has been transferred to another agency role, Fierce Pharma has learned.

Drastic overhauls of U.S. vaccine…

December 4th, 2025|Fierce Pharma|

Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.

The Buckland Group launched Quvara…

December 4th, 2025|Fierce Pharma|

The Buckland Group launched Quvara Medical as the newest CDMO to debut this year after buying a former Becton Dickinson manufacturing site in the U.K. for an undisclosed price.

China biopharma contracting…

December 4th, 2025|Fierce Pharma|

China biopharma contracting juggernaut WuXi AppTec faces a new threat that its extensive business ties to the U.S. could be imperiled as the Pentagon has identified the company as one of eight that assist the

Cosmo Pharmaceuticals has revealed…

December 3rd, 2025|Fierce Pharma|

Cosmo Pharmaceuticals has revealed topline results from two phase 3 trials which indicate that its topical cream clascoterone could become a game-changing treatment for male-pattern hair loss.

A federal appeals court has…

December 3rd, 2025|Fierce Pharma|

A federal appeals court has overturned a previous ruling out of Texas that required Daiichi to pay $41.8 million in Enhertu royalties, plus an 8% running royalty rate, to its former ADC partner, Seagen.

Johnson & Johnson has teamed…

December 3rd, 2025|Fierce Pharma|

Johnson & Johnson has teamed up with Naomi Watts to put a clearer focus on vision health, leveraging the actor’s star power to encourage women over 40 to make eye exams part of their self-care

The highly anticipated Adept-2…

December 3rd, 2025|Fierce Pharma|

The highly anticipated Adept-2 study data will not read out by year-end as previously planned after BMS identified “irregularities due to clinical trial execution at a small number of study sites,” the company said Wednesday.

Excelsior Sciences, which spun out…

December 3rd, 2025|Fierce Pharma|

Excelsior Sciences, which spun out of investment firm Deerfield Management, has roped in $95 million to scale its chemical synthesis "smart bloccs" platform, invest in its internal pipeline and forge partnerships across the industry, including

A Ferring Pharmaceuticals survey…

December 3rd, 2025|Fierce Pharma|

A Ferring Pharmaceuticals survey has found 39% of people undergoing fertility treatment are at least considering leaving their jobs, leading the drugmaker to question whether companies are doing enough to support employees.

Tuesday, the European Council…

December 2nd, 2025|Fierce Pharma|

Tuesday, the European Council gathered behind new regulations that seek to diversify local biopharma supply chains, support collaborative drug procurement models and devise incentives to bolster drug production in the bloc.

The U.S. House of Representatives…

December 2nd, 2025|Fierce Pharma|

The U.S. House of Representatives has given a unanimous thumbs up to the Give Kids A Chance Act, which would revive the FDA’s rare pediatric review voucher program following its expiration in December of last