FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA rejects Gilead’s next big HIV drug over glass vial issues

4 years ago

Deserted by Sanofi, Lexicon discloses last-minute hiccup in its solo fight to get sotagliflozin approved

4 years ago

'We are ready to go': FDA OKs J&J and Legend's BCMA CAR-T, setting stage for showdown with Bristol Myers

4 years ago

Hold the phone, biopharma: FDA-imposed clinical holds are on the rise

4 years ago

After being ushered onto the inside lane at FDA, regulators hand Amryt a CRL for rare disease drug

4 years ago

FDA rejects Reata's kidney drug after adcomm voted unanimously against it

4 years ago

More than 100 House and Senate Republicans call on new FDA commish to reverse order on mail-order abortion pills

4 years ago

Watch out, Novartis: Eli Lilly, Boehringer Ingelheim notch broad heart failure OK for Jardiance

4 years ago

AstraZeneca's Evusheld and GSK's sotrovimab lose efficacy against Omicron's subvariants

4 years ago

Orphazyme runs into another setback as Europe appears unlikely to approve its FDA-rejected drug

4 years ago

Public Citizen picks apart Cures 2.0 draft legislation, criticizing several RWE provisions

4 years ago

When a citizen petition works: FDA's review of United Therapeutics' PAH drug extended to May

4 years ago

Canada wants to clear the way for more decentralized clinical trials: Will the US follow suit?

4 years ago

FDA+ roundup: Assessor finds FDA's new biosimilar review model makes the process more predictable

4 years ago

Almost 9 in 10 Americans want the FDA to explain why some drugs are rejected, new JAMA survey finds

4 years ago

FDA slams former CytoDyn CEO's misleading interview in new warning letter

4 years ago

Tiny pharma hits a new low with FDA refusing to review company's response to its CRL

4 years ago

FDA updates Merck's Covid-19 pill EUA and reaffirms it should only be used as a last resort

4 years ago

FDA starts probe into a clinical trial death as next-gen CAR-T researchers stop enrollment

4 years ago

BioMarin gene therapy could be on hold 'for several quarters' after FDA mandates new preclinical tests

4 years ago

After selling off Tibsovo and entire cancer pipeline, Agios nets first approval for new 'anchor product'

4 years ago

FDA says volume manufacturing deadline is not a requirement after drugmakers lash out

4 years ago

Editorial: With Califf confirmed, FDA needs to return to priorities lost to the pandemic and improve its messaging

4 years ago

After an about-face on a PhIII trial, FDA sets up an adcomm to review controversial ALS drug next month

4 years ago

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