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FDA
Makary Got His Man in Pazdur—But Can He Last as CDER Director?
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
November 18, 2025
·
6 min read
·
Heather McKenzie
Cardiovascular disease
Merck Extends Winrevair’s Win Streak With New Mid-Stage Data in Type of Hypertension
Winrevair yielded significant and meaningful clinical benefits for patients with combined post- and precapillary pulmonary hypertension, an indication that, according to BMO Capital Markets, has few treatment options.
November 18, 2025
·
2 min read
·
Tristan Manalac
Antibody-drug conjugate (ADC)
Genmab Prunes Another ADC From $1.8B ProfoundBio Acquisition
Only one clinical-stage asset from the ProfoundBio acquisition remains in development: The antibody-drug conjugate Rina-S, in late-stage studies for ovarian and endometrial cancer.
November 18, 2025
·
2 min read
·
Tristan Manalac
Layoffs
Nxera’s Quest for Profitability Claims 15% of Workforce
Nxera, which formerly went by Sosei, will also reprioritize its pipeline to focus on obesity, metabolic and endocrine diseases.
November 18, 2025
·
2 min read
·
Tristan Manalac
Stomach cancer
Jazz, Zymeworks Bispecific Achieves ‘Practice-Changing’ Results in Stomach Cancer Study
With positive data from the Phase III HERIZON-GEA-01 study, Zymeworks and Jazz Pharmaceuticals will file an approval application for Ziihera in the first half of 2026 for the treatment of gastroesophageal adenocarcinoma.
November 18, 2025
·
2 min read
·
Tristan Manalac
Layoff Tracker
Merck Continues Cuts With 204 Laid Off in New Jersey
Follow along as
BioSpace
tracks job cuts and restructuring initiatives.
November 18, 2025
·
86 min read
·
BioSpace Editorial Staff
Press Releases
MediciNova Appoints Dr. Christopher Breder, MD, PhD as Clinical and Regulatory Advisor
November 18, 2025
·
5 min read
Press Releases
Emulate Launches Brain-Chip R1 to Advance Neurological Drug Development, in Partnership with FUJIFILM Cellular Dynamics
November 18, 2025
·
6 min read
Press Releases
Invivyd Announces Pricing of $125 Million Public Offering of Common Stock and Pre-Funded Warrants
November 18, 2025
·
5 min read
Press Releases
Apollomics Announces Changes to its Board of Directors and Composition of Committees
November 18, 2025
·
4 min read
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