Approvals
Stay up-to-date with the latest drug approvals by regulatory agencies worldwide. Gain insights into the regulatory processes, safety evaluations, and efficacy assessments. Stay informed about the new treatments available to patients and the impact they have on healthcare practices.
Eisai has requested to approve Leqembi, its therapy for Alzheimer’s disease, in South Korea
This filing comes just before an FDA advisory committee meeting, which has raised expectations of the drug receiving full approval ...
FDA accepts Merck’s application for Keytruda plus chemo in liver cancer
The FDA has granted acceptance to Merck’s application for the popular drug Keytruda, in combination with standard-of-care chemotherapy (gemcitabine plus ...
FDA Grants Approval to ABRYSVO, Pfizer’s Vaccine for Preventing Respiratory Syncytial Virus (RSV) in Elderly Individuals
The FDA, on May 31, 2023, granted approval to ABRYSVO (Respiratory Syncytial Virus Vaccine), Pfizer’s bivalent RSV prefusion F (RSVpreF) ...
BRIUMVI Receives Green Light from European Commission as Treatment for Relapsing Multiple Sclerosis
The European Commission (EC) gave the green light for the use of TG Therapeutics‘ BRIUMVI (ublituximab-xiiy) to treat relapsing forms ...
Indivior Receives FDA Approval for OPVEE (nalmefene)
Indivior’s OPVEEĀ® (nalmefene) nasal spray has received FDA approval for the emergency treatment of opioid overdose in adults and pediatric ...
Epkinly: FDA-Approved Bispecific Antibody for DLBCL
On May 19, 2023, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted approval to EPKINLYTM (epcoritamab-bysp) as ...
LEXICON ANNOUNCES FDA APPROVAL OF INPEFA (SOTAGLIFLOZIN) FOR TREATMENT OF HEART FAILURE
Lexicon Pharmaceuticals on May 26, 2023 announced that the US Food and Drug Administration (FDA) has approved INPEFAā¢ (sotagliflozin), a once-daily ...
ALLERGANāS LATEST SKIN-SMOOTHING PRODUCT HAS RECEIVED FDA APPROVAL, FEATURING A UNIQUE DELIVERY MECHANISM
Allergan has recently obtained FDA approval for its groundbreaking skincare product, Skinvive, which is part of the Juvederm dermal filler ...
EPCORITAMAB RECEIVES FDA APPROVAL FOR RELAPSED/REFRACTORY DLBCL
The FDA has granted approval to epcoritamab-bysp (Epkinly), the first T-cellāengaging bispecific antibody, for the treatment of relapsed/refractory diffuse large ...
