Breakthrough FDA approval of targeted leukemia drug has ties to Roswell Park

A major breakthrough in the treatment of an aggressive form of leukemia is bringing new hope to patients and it started in ...
Targeted Oncology

FDA Grants Full Approval to Tarlatamab in Small Cell Lung Cancer

The FDA has granted full approval to tarlatamab-dlle (Imdelltra) for the treatment of adult patients with extensive stage ...

IMDELLTRA's FDA Approval and Guideline Upgrade Could Be a Game Changer for Amgen (AMGN)

Amgen recently announced that the FDA granted full approval to IMDELLTRA (tarlatamab-dlle) for adults with extensive stage ...

Jaguar Health Makes Submission to EMA Regarding EU Approval Pathway for Canalevia for General Diarrhea in Dogs Based on Data from Completed Study

Jaguar’s requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia® A ...
Seeking Alpha

Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory ...

GERMANTOWN, Md, Aug. 15, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of ...
abc13

Pfizer and BioNTech begin application for full FDA approval of their COVID-19 vaccine

Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said Friday. This is the ...
Fierce Pharma

In crowded kidney disease space, Otsuka receives FDA approval for first-in-class Voyxact

A new FDA approval for a first-in-class drug has vaulted Otsuka into immunoglobulin A nephropathy (IgAN), an increasingly competitive kidney disease field targeted by multiple biopharma companies.

Amgen Lung Cancer Drug Gets Full Approval From FDA

Amgen's Imdelltra received full approval from the Food and Drug Administration for use in patients with lung cancer. The biotechnology company said Wednesday Imdelltra received approval for adult ...
6abc News

Pfizer says COVID vaccine protection lasts at least 6 months; Company can now seek full FDA approval

The ongoing Phase 3 clinical trial of Pfizer/BioNTech's coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday. The companies can now ...
Scientific AmericanOpinion

Changing the FDA's Vaccine Approval Process Could Threaten COVID, Flu Protection for Children

Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...
abc7NY

FDA approves updated COVID-19 shots but limits access for some kids and adults

U.S. regulators approved updated COVID-19 shots Wednesday but limited their use for many Americans - and removed one of the two vaccines available for young children. The new shots from Pfizer, ...

PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)

Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval PathwayPRINCETON, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ...