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
184,603 Results
Type
Article (12697)
Company Profile (8)
Press Release (171898)
Section
Business (45141)
Career Advice (66)
Deals (7734)
Drug Delivery (46)
Drug Development (34597)
Employer Resources (13)
FDA (14743)
Job Trends (4249)
News (108485)
Policy (19976)
Tag
Academia (337)
Allergies (35)
Alliances (9906)
Alzheimer's disease (557)
Antibody-drug conjugate (ADC) (48)
Approvals (14619)
Artificial intelligence (36)
Bankruptcy (88)
Best Places to Work (3768)
Biosimilars (58)
Breast cancer (68)
Cancer (520)
Cardiovascular disease (52)
Career advice (64)
CAR-T (46)
Cell therapy (117)
Clinical research (28715)
Collaboration (112)
Compensation (37)
COVID-19 (1296)
Data (499)
Diabetes (82)
Diagnostics (1929)
Earnings (23099)
Events (20966)
Executive appointments (84)
FDA (15263)
Funding (97)
Gene therapy (110)
GLP-1 (312)
Government (2450)
Healthcare (4730)
Infectious disease (1345)
Inflammatory bowel disease (46)
IPO (4020)
Job creations (630)
Job search strategy (60)
Layoffs (144)
Legal (2130)
Liver cancer (40)
Lung cancer (102)
Manufacturing (58)
Medical device (5554)
Medtech (5557)
Mergers & acquisitions (3729)
Metabolic disorders (211)
Neuroscience (715)
NextGen Class of 2024 (1239)
Non-profit (496)
Northern California (525)
Obesity (117)
Opinion (100)
Patents (51)
People (10385)
Phase I (6893)
Phase II (11778)
Phase III (12788)
Pipeline (258)
Postmarket research (1113)
Preclinical (1975)
Radiopharmaceuticals (97)
Rare diseases (134)
Real estate (769)
Regulatory (16516)
Research institute (361)
Schizophrenia (34)
Southern California (504)
Startups (556)
United States (4953)
Vaccines (309)
Weight loss (106)
Date
Today (41)
Last 7 days (285)
Last 30 days (1494)
Last 365 days (13871)
2024 (12688)
2023 (15066)
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 (43)
Asia (10402)
Australia (2114)
California (1232)
Canada (450)
China (77)
Colorado (55)
Connecticut (57)
Europe (20124)
Florida (207)
Georgia (43)
Illinois (86)
Indiana (75)
Kansas (40)
Maryland (314)
Massachusetts (777)
Minnesota (114)
New Jersey (473)
New York (396)
North Carolina (266)
Northern California (525)
Ohio (47)
Pennsylvania (307)
South America (173)
Southern California (504)
Texas (159)
Utah (35)
Washington State (85)
184,603 Results for "fda".
Filters
Sort By
Relevance
Relevance
Newest
Oldest
FDA Tracker
Jazz, Zymeworks Challenge Enhertu with FDA Win for Bispecific Antibody
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.
November 21, 2024
·
204 min read
·
Heather McKenzie
FDA
FDA Action Alert: Journey, Merus, PTC and Autolus
The FDA is set to decide on four promising therapies in the next two weeks, including a CAR T for acute lymphoblastic leukemia.
November 4, 2024
·
4 min read
·
Tristan Manalac
FDA
Lykos Announces ‘Productive’ Meeting With FDA Regarding Rejected MDMA Drug
In a short statement Friday, Lykos Therapeutics expressed optimism about a recent meeting with the regulator to discuss next steps for the embattled program, following the FDA’s rejection in August 2024.
October 21, 2024
·
1 min read
·
Heather McKenzie
Cancer
Adaptimmune Plots Path to FDA as Sarcoma Cell Therapy Aces Pivotal Trial
Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025.
November 14, 2024
·
2 min read
·
Tristan Manalac
Regulatory
Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
October 23, 2024
·
2 min read
·
Tristan Manalac
Adcomms
Stealth’s Ultrarare Disease Candidate Might Not Meet Bar for Approval: FDA
The FDA’s reviewers pointed out that Stealth’s elamipretide missed its primary efficacy endpoints in the main study used to establish its effectiveness.
October 9, 2024
·
2 min read
·
Tristan Manalac
Approvals
PTC Wins First FDA Nod for Direct-to-Brain Gene Therapy, Targets Ultrarare Disease
The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene therapy Kebilidi for AADC deficiency. It is the first approved gene therapy to be delivered directly to the brain.
November 14, 2024
·
2 min read
·
Tristan Manalac
Adcomms
Lexicon Loses FDA Adcomm Vote on Insulin Adjunct for Patients With Type 1 Diabetes
While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external experts found that the company did not provide enough data to support its drug application.
November 1, 2024
·
2 min read
·
Tristan Manalac
Regulatory
FDA Action Alert: Amgen, Camurus, Iterum and Lexicon
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.
October 14, 2024
·
4 min read
·
Tristan Manalac
Regulatory
FDA Action Alert: Biofrontera, BMS and Zealand
One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting.
September 30, 2024
·
4 min read
·
Tristan Manalac
1 of 18,461
Next
