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FDA+ channel feed
Operation Warp Speed for rare diseases: CBER leader says pilot is coming soon
3 years ago
Japan cancels 140M dose order for Novavax Covid vaccine amid 'lower than expected' demand
3 years ago
Pharma
FDA hands down a partial hold for PhI/II trial of Blueprint’s CDK2 inhibitor
3 years ago
Still no green light for Phathom's gastrointestinal drugs after impurities found in batches
3 years ago
FDA advisors vote 8-5 in favor of GSK's Jemperli trial plan for rare rectal cancer
3 years ago
R&D
UK microcap faces partial clinical hold in mid-stage IPF trial
3 years ago
R&D
FDA commissioner floats ideas on how to better handle the pandemic
3 years ago
FDA assembles adcomm to review GSK's Jemperli trial plans in rectal cancer
3 years ago
R&D
Biden to tout pharma's defeat in State of the Union, call for $35 insulin for all
3 years ago
Law
Updated: Biden's science team sees another mini-transition as Alondra Nelson departs
3 years ago
People
Sage, Biogen set their sights on a summer PDUFA deadline as zuranolone decision looms
3 years ago
FDA places hold on 4D Molecular’s Fabry gene therapy
3 years ago
Cell/Gene Tx
Trodelvy notches a win in most common form of breast cancer
3 years ago
FDA approves GSK's anemia drug with safety warning — after batting back similar drugs
3 years ago
Pharma
FDA axes requirement for positive Covid test before Paxlovid use
3 years ago
Coronavirus
Pfizer brings Ibrance to new subset of breast cancer patients, regardless of menopausal status
3 years ago
Pharma
Amid application tsunami, FDA's top cell and gene therapy leader to retire in March
3 years ago
People
Pandemic wait is over: FDA begins transition to in-person meetings in March
3 years ago
Covid public health emergencies to end in May, but FDA's EUA authority will continue
3 years ago
Pharma
Coronavirus
Oracle executive Troy Tazbaz named new FDA director of digital health
3 years ago
People
Pharma
FDA approves Italy-based pharma's oral SERD for some breast cancer patients
3 years ago
Novavax gets ready to take another shot at Covid vaccine market with next season plans
3 years ago
Pharma
Post-hoc analysis: EMA's CHMP rejects Ipsen's potential drug for rare genetic disease
3 years ago
Pharma
FDA approves another indication for Keytruda, this time in the adjuvant NSCLC setting
3 years ago
R&D
Pharma
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