FDA+ channel feed – Endpoints News

FDA+ channel feed

Samsung Bioepis strikes deal for Stelara biosimilar, but launch likely won't come in time for an IRA exemption

Last year

Apellis' eye disease drug gets safety label update for rare inflammation side effect

Last year

More companies need to set diversity enrollment goals in cancer trials, FDA says

Last year

FDA ships Form 483 to generic drug giant Dr. Reddy’s due to equipment issues, other observations

Last year

Clinicians say benefits of CAR-T continue to outweigh risk of T-cell malignancies

Last year

Senate Finance Committee to review federal policies on drug shortages

Last year

Intas Pharmaceuticals' Indian facility hit with FDA warning letter, placed on import alert

Last year

FDA to make decision about Karuna's schizophrenia drug by next September

Last year

FDA opens review of CAR-T safety after identifying 19 cases of post-treatment blood cancer

Last year

Aldeyra's dry eye drug gets a rejection from the FDA

Last year

SpringWorks Therapeutics ready to launch newly-approved desmoid tumor treatment after three-month delay

Last year

Marks: FDA open to using single-arm studies for accelerated approval of rare disease gene therapies

Last year

FDA to SCOTUS: Setting the mifepristone regulations clock back to 2016 is 'unjustified'

Last year

FDA warns Genentech clinical investigator working on preventive flu antiviral trial

Last year

FDA warns Cipla's albuterol inhaler plant after thousands of complaints

Last year

Improper Orange Book listings harm competition, FTC says in amicus brief to antitrust suit

Last year

Bernie Sanders invites CEOs of J&J, Merck, Bristol Myers to testify on drug pricing

Last year

Ascendis Pharma's hypoparathyroidism drug scores European approval after refiling in the US

Last year

New FDA rule for pharma advertisements requires side effects to be explained clearly

Last year

Senate Democrats press AstraZeneca, Sanofi on RSV antibody shortage

Last year

Bristol Myers and 2seventy bio say FDA delayed CAR-T therapy decision

Last year

Pfizer, Astellas clinch expanded approval for Xtandi in earlier line of prostate cancer

Last year

Biden taps Vanderbilt’s Kimryn Rathmell to succeed Bertagnolli as the NIH's cancer chief

Last year

Merck notches 38th approval for Keytruda, seventh indication for gastrointestinal cancer

Last year

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