News
Drug Development
FDA
Drug Delivery
Deals
Business
Policy
Cell and Gene Therapy
Weight Loss
Rare Disease
Cancer
Job Trends
Artificial Intelligence
NextGen: Top Start Ups to Watch
Podcasts
Reports
Webinars
Press Releases
All News & Releases
Insights
Jobs
Career Advice
Companies
Hotbeds
More
Best Places to Work
Employer Resources
Post Jobs
Talent Solutions
Advertise
Submit a Press Release
SUBSCRIBE
Menu
SUBSCRIBE
Show Search
News
Drug Development
FDA
Drug Delivery
Deals
Business
Policy
Cell and Gene Therapy
Weight Loss
Rare Disease
Cancer
Job Trends
Artificial Intelligence
NextGen: Top Start Ups to Watch
Podcasts
Reports
Webinars
Press Releases
All News & Releases
Insights
Jobs
Career Advice
Companies
Hotbeds
More
Best Places to Work
Employer Resources
Post Jobs
Talent Solutions
Advertise
Submit a Press Release
Search Query
Submit Search
Search Results
Submit
Looking for jobs?
Search jobs
Close
185,513 Results
Type
Article (12766)
Company Profile (9)
Press Release (172738)
Section
Business (45163)
Career Advice (66)
Deals (7739)
Drug Delivery (48)
Drug Development (34638)
Employer Resources (13)
FDA (14762)
Job Trends (4250)
News (108554)
Policy (19986)
Tag
Academia (337)
Allergies (39)
Alliances (9936)
Alzheimer's disease (571)
Antibody-drug conjugate (ADC) (53)
Approvals (14645)
Artificial intelligence (42)
Bankruptcy (88)
Best Places to Work (3791)
Biosimilars (62)
Breast cancer (96)
Cancer (645)
Cardiovascular disease (63)
Career advice (64)
CAR-T (51)
Cell therapy (136)
Clinical research (28950)
Collaboration (133)
Compensation (49)
COVID-19 (1302)
Data (617)
Diabetes (94)
Diagnostics (1943)
Earnings (23118)
Events (21132)
Executive appointments (109)
FDA (15412)
Funding (114)
Gene therapy (119)
GLP-1 (325)
Government (2454)
Healthcare (4738)
Infectious disease (1356)
Inflammatory bowel disease (46)
IPO (4028)
Job creations (630)
Job search strategy (60)
Layoffs (145)
Legal (2135)
Liver cancer (41)
Lung cancer (120)
Lymphoma (52)
Manufacturing (66)
Medical device (5568)
Medtech (5571)
Mergers & acquisitions (3743)
Metabolic disorders (238)
Neuroscience (751)
NextGen Class of 2024 (1239)
Non-profit (497)
Northern California (603)
Obesity (131)
Opinion (101)
Patents (60)
People (10434)
Phase I (6953)
Phase II (11874)
Phase III (12881)
Pipeline (279)
Postmarket research (1120)
Preclinical (1989)
Radiopharmaceuticals (97)
Rare diseases (162)
Real estate (769)
Regulatory (16638)
Research institute (362)
Southern California (568)
Startups (556)
United States (5624)
Vaccines (317)
Weight loss (114)
Date
Last 7 days (237)
Last 30 days (890)
Last 365 days (13648)
2024 (13596)
2023 (15068)
2022 (17366)
2021 (18510)
2020 (17648)
2019 (11650)
2018 (9014)
2017 (10222)
2016 (8639)
2015 (9933)
2014 (7119)
2013 (5406)
2012 (5971)
2011 (6015)
2010 (5758)
Location
Africa (102)
Arizona (45)
Asia (10454)
Australia (2126)
California (1422)
Canada (499)
China (94)
Colorado (69)
Connecticut (67)
Europe (20232)
Florida (234)
Georgia (51)
Illinois (106)
Indiana (83)
Kansas (40)
Maryland (342)
Massachusetts (899)
Minnesota (123)
New Jersey (549)
New York (439)
North Carolina (283)
Northern California (603)
Ohio (51)
Pennsylvania (339)
South America (173)
Southern California (568)
Texas (195)
Utah (41)
Washington State (99)
185,513 Results for "fda".
Filters
Sort By
Relevance
Relevance
Newest
Oldest
Regulatory
Deep Dive: FDA’s Accelerated Approval Pathway Under Fire
In this deep dive
BioSpace
explores the opportunities and challenges presented by the FDA’s accelerated approval program.
November 18, 2024
·
2 min read
·
Heather McKenzie
Postmarket research
Intercept’s Troubled Drug Ocaliva Linked to ‘Serious Liver Injury’: FDA
Ocaliva recently failed to secure the FDA’s traditional approval for primary biliary cholangitis due to safety concerns.
December 13, 2024
·
2 min read
·
Tristan Manalac
Regulatory
FDA Action Alert: Ionis, Lexicon, Bristol Myers Squibb and More
The FDA’s year-end rush includes nine target action dates, mostly for rare disease and cancer therapies.
December 9, 2024
·
7 min read
·
Tristan Manalac
Drug shortages
Legal Challenge Over Lilly’s GLP-1 Shortages Highlights FDA’s Post-Chevron Vulnerability
Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.
November 26, 2024
·
4 min read
·
Ben Hargreaves
Complete response letters
J&J’s FDA Bid for Subcutaneous Rybrevant Falls Short
The FDA cited issues with a manufacturing facility as the reason for the rejection. J&J is currently “working closely” with the regulator to resolve these problems.
December 17, 2024
·
2 min read
·
Tristan Manalac
FDA Tracker
Zealand’s GLP-2 Drug Rejected While Xcovery Wins First Approval, Targets NSCLC
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as
BioSpace
keeps you up to date on all of the FDA’s decisions in 2024.
December 20, 2024
·
221 min read
·
BioSpace Editorial Staff
Cell therapy
Mesoblast Wins First Mesenchymal Stromal Cell Therapy FDA Approval for GVHD
The approval concludes what has been a difficult regulatory path for Ryoncil, which suffered FDA rejections in 2020 and 2023.
December 19, 2024
·
2 min read
·
Tristan Manalac
GLP-1
FDA Issues Warning Letters Against Online GLP-1 Sellers
The letters come amid the Outsourcing Facilities Association’s ongoing lawsuit against the FDA over the regulator’s decision to end the shortage for tirzepatide.
December 18, 2024
·
2 min read
·
Tristan Manalac
Duchenne Muscular Dystrophy
Déjà Vu for PepGen as FDA Places Hold on DMD Drug
The FDA has put a stop to U.S. initiation of PepGen’s Phase II trial for its Duchene muscular dystrophy treatment. The company faced the same hurdle for an earlier neuromuscular candidiate in 2023.
December 16, 2024
·
2 min read
·
Annalee Armstrong
Drug shortages
FDA Confirms Lilly’s GLP-1s Are Not in Shortage, Gives Compounders Grace Period
After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
December 19, 2024
·
3 min read
·
Tristan Manalac
1 of 18,552
Next
