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AstraZeneca BLA for Tezepelumab as Asthma Therapy

[ Price : $8.95]

AstraZeneca submits a BLA for tezepelumab, a potential first-in-class medicine for treating severe asthma.

ICH Q12 Technical, Regulatory Consideration Annex

[ Price : $8.95]

FDA publishes an International Council for Harmonization final guidance on technical and regulatory considerations for postapprova...

Bayer: More Positive Kidney Disease Drug Data

[ Price : $8.95]

Bayer reports positive data from a second Phase 3 study that evaluated the safety and efficacy of finerenone versus placebo when a...

Liquidia Refiles NDA for Pulmonary Hypertension

[ Price : $8.95]

Liquidia resubmits its NDA for LIQ861 for treating pulmonary arterial hypertension.

2 FDA-483s Issued to Clinical Investigators

[ Price : $8.95]

FDA posts two 2019 Form FDA-483s after inspecting two Hennepin County Medical Center clinical investigators who were cited for stu...

FDA Expands Pfizer Covid Vaccine to 12-15 Year Olds

[ Price : $8.95]

FDA expands the emergency use authorization for Pfizer-BioNTechs Covid-19 vaccine to include adolescents aged 12 through 15 years....

Info Collection on Registration/Listing Revised

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled Registration of Producers of Drugs and ...

Vaccines Panel to Discuss Pediatric Covid Vaccines

[ Price : $8.95]

FDA announces a 6/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss Covid-19 vaccines and their us...

FDA Asked to Drop Clinical Hold on Party Drug

[ Price : $8.95]

The Multidisciplinary Association for Psychedelic Studies asks FDA to remove a clinical hold against a study designed to assess th...

Bolder Surgical Vessel Sealer Expanded Indication

[ Price : $8.95]

FDA clears a Bolder Surgical 510(k) for an expanded indication for the CoolSeal Trinity 5 mm Laparoscopic Vessel Sealer, Divider, ...