FDA+ channel feed – Endpoints News

FDA+ channel feed

CEO Ugur Sahin: BioNTech and Pfizer will file for a Covid-19 vaccine EUA on Friday

5 years ago

Amid scrutiny of exec stock sales, SEC chairman echoes calls for 'cooling-off period' in trading plans

5 years ago

Analysts poured cold water, but FDA gives a fast-pass for Sanofi's new Pompe disease drug

5 years ago

Updated: FDA gives Cellectis all clear after patient death halted off-the-shelf CAR-T trial

5 years ago

GSK and ViiV score breakthrough therapy designation in HIV prevention, as Truvada showdown draws nearer

5 years ago

Alkermes is handed a CRL for ‘3831, marking another setback on the R&D front

5 years ago

Penny stock player Adamis gets another CRL for high-dose naloxone as shares crater

5 years ago

Apellis' Soliris rival gets a date at the FDA for a rare blood disorder, with potentially $400M worth of implications

5 years ago

Bristol Myers' $9 Celgene CVR is teetering on the brink of disaster as the FDA delays the liso-cel application yet again

5 years ago

Sanofi grapples with rejection of potential first-in-class orphan drug, faults third-party manufacturing

5 years ago

Merck's Keytruda nets another approval, this time in triple negative breast cancer. Can it catch up to Tecentriq?

5 years ago

BioMarin CEO Bienaimé beats a retreat from Europe, yanking their application for hemophilia A gene therapy

5 years ago

CDER's Janet Woodcock: Pharma, regulators have lessons to learn from Covid-19

5 years ago

French health products agency yanked into legal battle over birth defects caused by Sanofi's Depakine

5 years ago

Expected mistakes, the need for speed, and change to come: CBER's Peter Marks looks ahead

5 years ago

A few months after emerging from stealth, Praxis is handed a clinical hold for lead depression drug

5 years ago

FDA hits Supernus with double whammy, handing biotech a CRL and RTF on same day

5 years ago

Covid-19 roundup: With efficacy data in hand, BioNTech talks pricing; Brazil halts Sinovac trial following patient death

5 years ago

Sweeping doubts aside, Eli Lilly beats Regeneron to emergency OK — clearing low dose antibody for quick rollout

5 years ago

Now that Biogen’s aducanumab team and the FDA’s Billy Dunn have been battered by a gamut of angry experts, the analysts are weighing in

5 years ago

Expert panel review on Alzheimer’s drug aducanumab becomes a one-day trial by fire as critics turn their guns on Biogen — and the FDA

5 years ago

AstraZeneca gets a much-needed boost for blood thinner Brilinta with an OK on stroke

5 years ago

The FDA's insider review on aducanumab was all about politics, not science, and it threatens patients and the biopharma industry alike

5 years ago

Citing pandemic, Sarepta defers much-anticipated DMD gene therapy PhIII, will head to regulators after 10-person study

5 years ago

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