The Pharma Data

DECEMBER 5, 2020

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

OCTOBER 28, 2020

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

Virus 40

Virus Trials Clinical Trials Production 40

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. Phage therapies are sold at a pharmacy in Georgia.

Therapies 137

Therapies Virus DNA Clinical Trials 137

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

JANUARY 12, 2021

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

Government 52

Government Hospitals Virus Clinical Trials 52

The Pharma Data

NOVEMBER 20, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

NOVEMBER 5, 2020

The FDA accepted for priority review, with a target action date of February 28, 2021 , the supplemental Biologics License Application (sBLA) for Libtayo ® (cemiplimab) as monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ?50% Oncology Program. 50% PD-L1 expression.

Production 40

Production FDA Trials FDA Approval 40

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

The Pharma Data

NOVEMBER 21, 2020

The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available.

FDA 40

FDA Clinical Trials Hospitals Production 40

The Pharma Data

DECEMBER 29, 2020

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest. Priority B List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

Drug Target Review

APRIL 11, 2025

Drug development is hampered by high costs, long timelines and a low probability of success and complex therapies exacerbate these challenges. Even excluding repositioned drugs, which could benefit from pre-existing toxicology and clinical data, a significant increase in PoS is still observed. This is an AI-generated image.

Clinical Development 97

Clinical Development Drugs Pharmaceuticals Clinical Trials 97

The Pharma Data

OCTOBER 14, 2020

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

FDA Approval 52

FDA Approval FDA Production Treatment 52

Drug Target Review

MARCH 13, 2025

Planning the journey from data to deliverables The future of AI-enabled drug development benefits from the continued advancement of multimodality and clinical genomics, with a focus on integration, efficiency and personalisation to transform both care and R&D.

Drug Development 59

Drug Development Science Clinical Trials Drugs 59

Drug Target Review

FEBRUARY 11, 2025

Drug development: addressing complexity and success rates Drug development is a complex and expensive process, requiring multidisciplinary expertise and high-risk financial investments. The financial burden of drug development is substantial, often exceeding $2 billion per drug.

Drug Development 59

Drug Development Bioinformatics Drugs Small Molecule 59