Regulatory Oversight and Compliance

Will Decentralized Clinical Trials Become Mainstream?

March 25, 2022

Pharma’s interest in decentralized clinical trials (DCTs) increases as it helps to expand their geographical reach and racial diversity

FDA Grants Breakthrough Therapy Designation for Pfizer Respiratory Syncytial Virus Vaccine Candidate

March 25, 2022

Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults.

EMA Grants Recommendation for New Gene Therapy to Treat Adult Patients with Multiple Myeloma

March 25, 2022

EMA has recommended a conditional marketing authorization for a new gene therapy to treat adult patients with multiple myeloma.

FDA and Congress Re-Examine Accelerated Approval Program

March 24, 2022

Congress is considering revising and improving policies related to drug development and regulation for possible inclusion in broader legislation to reauthorize FDA user fees.

RINVOQ Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

March 23, 2022

FDA has approved RINVOQ as a treatment for adults with moderately to severely active ulcerative colitis who have not had an adequate response to existing treatments.

FDA Approves Opdualag for Unresectable or Metastatic Melanoma

March 21, 2022

FDA has approved Opdualag for adults and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

Marinus Pharmaceuticals Announces FDA Approval of ZTALMY for CDKL5 Deficiency Disorder

March 21, 2022

FDA has approved ZTALMY as a treatment for seizures associated with CDKL5 deficiency disorder (CDD).

AstraZeneca’s Antibody Combination Authorized for Use in Great Britain for Prevention of COVID-19

March 21, 2022

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products

March 21, 2022

Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.

COVID-19 Vaccine Manufacturers Submit Appeals to FDA for Fourth Dose

March 21, 2022

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.