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Blog: FDA

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Why ease of administration in new drugs sometimes draws a yawn from payers Why ease of administration in new drugs sometimes draws a yawn from payers
Blog February 26, 2026
Why ease of administration in new drugs sometimes draws a yawn from payers
Biopharma Commercialization FDA
The path forward: What comes after a CRL? The path forward: What comes after a CRL?
Blog February 24, 2026
The path forward: What comes after a CRL?
Biopharma Biotech Clinical trials
Relacorilant:  when evidence meets the established evidence bar Relacorilant:  when evidence meets the established evidence bar
Blog February 24, 2026
Relacorilant: when evidence meets the established evidence bar
Biopharma Biotech Clinical trials
Tolebrutinib: when safety concerns override efficacy signals Tolebrutinib: when safety concerns override efficacy signals
Blog February 24, 2026
Tolebrutinib: when safety concerns override efficacy signals
Biopharma Biotech Clinical trials
Navigating Complete Response Letters: how Clarivate solutions can help pharmas chart their path to approval Navigating Complete Response Letters: how Clarivate solutions can help pharmas chart their path to approval
Blog February 24, 2026
Navigating Complete Response Letters: how Clarivate solutions can help pharmas chart their path to approval
Biopharma Biotech Clinical trials
Key market access considerations for long-acting and alternative delivery therapies Key market access considerations for long-acting and alternative delivery therapies
Blog February 20, 2026
Key market access considerations for long-acting and alternative delivery therapies
Biopharma Commercialization FDA
The market access “sweet spots” where payers reimburse more convenient therapies The market access “sweet spots” where payers reimburse more convenient therapies
Blog February 19, 2026
The market access “sweet spots” where payers reimburse more convenient therapies
Biopharma Commercialization FDA
How the Inflation Reduction Act could impact access to more convenient therapeutics How the Inflation Reduction Act could impact access to more convenient therapeutics
Blog February 17, 2026
How the Inflation Reduction Act could impact access to more convenient therapeutics
Biopharma Biotech Commercialization

FDA

Blog March 25, 2020
Do EMA and FDA review outcomes for new active substances (NASs) align?
Blog November 20, 2018
U.S. enhances malaria-fighting toolkit
Blog September 13, 2018
FDA actions to improve prescription drug labeling for pregnancy
Blog July 26, 2018
Improvements charted in reduction of time to new drug approvals at key regulatory authorities
Blog June 26, 2018
Regulatory considerations, strategy and best practices for choosing a quality CMO
Blog June 12, 2018
FDA focuses on drug supply chain security
Blog June 5, 2018
FDA efficacy recommendations vary for hypogonadotropic hypogonadism drugs
Blog March 6, 2018
Generics industry sets record for U.S. approvals, has ‘nothing to apologize for’
Blog December 14, 2017
Everything old is new again: bacteriophage therapy
Blog December 5, 2017
The impact of the changing regulatory environment on the approval of new medicines, 2007-2016