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Human Drugs

AFT Pharma Complete Response on Pain Killer Combo

FDA issues AFT Pharmaceuticals a complete response letter on its NDA for Maxigesic IV, a combination of 1,000 mg paracetamol and 300 mg ibuprofen solu...

Medical Devices

Philips and Biodesix Team Up on Lung Cancer Management

Royal Philips teams up with Biodesix to add the results of Biodesixs Nodify Lung blood-based lung nodule risk assessment testing into Philips Lung Can...

Biologics

Genmab Filing BLA for Large B-cell Lymphoma Therapy

Genmab says it will submit in the second half of this year a BLA for subcutaneous epcoritamab, an investigational bispecific antibody for treating pat...

Medical Devices

FDA OKs PreventionGenetics Companion Diagnostic

FDA approves PreventionGenetics POMC/PCSK1/LEPR companion diagnostic genetic test for use with Rhythm Pharmaceuticals Imcivree (setmelanotide), indica...

FDA General

FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 11.

Federal Register

FDA Seeks Consumer Reps for Advisory Committees

Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...

Human Drugs

FDA Copiktra Warning About Higher Risk of Death

FDA says clinical trial results show an increased risk of death and serious side effects associated with Secura Bios cancer drug Copiktra.

Biologics

Add Omicron BA.4/5 Component to Boosters: FDA

FDA tells Covid-19 vaccine manufacturers seeking to update their vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike ...

Comments on OPDP Research Proposal

Three drug company stakeholders suggest changes to research proposed by the CDER Office of Prescription Drug Promotion.

FDA General

Califf Adds 2 Senior Officials to Leadership Team

FDA commissioner Robert Califf taps former Johns Hopkins School of Medicine professor Namandj N. Bumpus as the agencys new chief scientist, and former...