FDA
FDA Issues Warning Letter to AstraZeneca Regarding ‘Misleading’ Breztri Efficacy Claims
AstraZeneca’s promotional campaign for Breztri Aerosphere, a treatment for chronic obstructive pulmonary disease (COPD), has encountered significant regulatory turbulence, with ...
Revance into Therapeutic Realm with FDA Approval for Cervical Dystonia Treatment, Daxxify
Revance, a prominent player in the aesthetics market, has now made a strategic move into the promising therapeutic arena. Following ...
Johnson & Johnson Takes Lead in Bispecific Antibody Approval for Multiple Myeloma, Leaving Pfizer in the Dust
The FDA has granted accelerated approval to talquetamab-tgvs, branded as Talvey, for treating relapsed or refractory multiple myeloma in adults ...
ABM-1310 receives Orphan Drug Designation from the FDA for Glioblastoma
Source – ABM Therapeutics ABM Therapeutics has received orphan drug designation from the FDA for ABM-1310, a novel small molecule ...
Merck’s Ervebo has received US FDA approval for use in children 12 months of age and older
Source – Merck Merck announced that the US Food and Drug Administration (FDA) has granted expanded approval for Ervebo. The ...
Endometrial Cancer Patients Get New Option with Jemperli
Source – GSK GSK has secured approval from the US for Jemperli, in combination with chemotherapy, as a first-line treatment ...
Lonsurf gets a boost from FDA for colorectal cancer, challenging rivals Takeda and Hutchmed
Source – Taiho OncologyĀ Eight years after initially gaining FDA approval for the treatment of heavily pretreated colorectal cancer, Taiho ...
IVS-3001 been given Fast Track Designation by the FDA for RCC
The FDA has granted fast track designation (FTD) to IVS-3001, an innovative chimeric antigen receptor (CAR) T-cell therapy, intended for ...
FDA rejects Citius’ resurrected IL-2 lymphoma treatment
Source – Citius PharmaceuticalsĀ The FDA has declined Citius Pharmaceuticals’ request to market Lymphir, an updated version of a lymphoma ...
Eli Lilly’s Tirzepatide Succeeds in 2 More Late-Stage Obesity Trials Ahead of FDA Decision
Source – Eli Lilly Eli Lilly continues to gather strong evidence supporting the effectiveness of tirzepatide, its dual GIP/GLP-1 agonist, ...
Bristol Myers lowers the company’s 2023 revenue forecast for Revlimid by $1 billion
Bristol Myers Squibb (BMS) had a promising long-term outlook after securing FDA approvals for three drugs with peak sales potential ...
Balfaxar, a warfarin reversal medication from Octapharma, receives FDA approval
Source – Octapharma More than 2.4 million individuals in the United States rely on warfarin, a blood thinner, to prevent ...
Tarsus’ Xdemvy is approved by the FDA as the first therapy for common eyelid illness
Source – Tarsus Pharmaceuticals Tarsus Pharmaceuticals has achieved a groundbreaking milestone with the FDA approval of Xdemvy, the first-ever treatment ...
Cabometyx patent battle is resolved by Exelixis and Teva with a 2031 generic license
Source – Exelixis Exelixis, the company behind the successful cancer drug Cabometyx, has been actively defending its intellectual property. In ...
FDA issues a warning notice to Centaur Pharmaceuticals detailing quality and sanitation violations
Centaur Pharmaceuticals, a company based in India, recently faced scrutiny from the FDA due to issues discovered during an inspection ...
FDA Grants Approval to Emergent’s Anthrax Vaccine Cyfendus After 4 Years of Supplying the Shot
Source – Emergent BioSolutons Emergent BioSolutions has been delivering its AV7909 anthrax vaccine to the Department of Health and Human ...
Selinexor Receives Fast Track Designation from FDA for Myelofibrosis Treatment
Source – Karyopharm Therapeutics The FDA has granted fast track designation to selinexor (Xpovio) for the treatment of patients with ...
Rivoceranib Plus Camrelizumab NDA for Unresectable HCC is Accepted by the FDA
Source – Elevar therapeutics On July 17, 2023, The FDA has accepted a New Drug Application (NDA) for rivoceranib, an ...
FDA Approves IND for Selected Advanced Solid Tumors Using ADRX-0706
Source – Adcentrx Therapeutics The FDA has granted clearance to Adventrx Therapeutics’ IND application for ADRX-0706, a promising treatment for ...
Catalentās Indiana Facility Faces FDA Observations After Eylea Rejection
Following an unexpected rejection from the FDA for Regeneron’s high-dose Eylea, the FDA disclosed issues related to cleaning and procedures ...
Apellisā Syfovre Linked to Eye Inflammation in Geographic Atrophy Patients
Source – Apellis Pharmaceuticals July 17, After receiving FDA approval for the treatment of advanced eye disease geographic atrophy, Apellis ...
FDA has approved Beyfortus as a treatment for RSV illness in newborns
Source – Sanofi On July 17, 2023 Sanofi and AstraZeneca received approval from the US Food and Drug Administration (FDA) ...
FDA Issues ODD for Gallium Maltolate for Pediatric GBM
Imaging Biometrics announced that gallium maltolate (GaM) has received orphan drug designation (ODD) from the FDA for the treatment of ...
FDA states that LN-145 in NSCLC is likely to receive accelerated approval
Source – Iovance Biotherapeutics The Phase II IOV-LUN-202 trial of LN-145 in patients with post-anti-PD-1 non-small cell lung cancer (NSCLC) ...
The Arrival of OTC birth control in the US
Source – FDA The US has approved the first-ever over-the-counter (OTC) contraceptive pill, providing women with a new option for ...
FDA-Approved Medications for Multiple Myeloma: What You Need to Know
Let’s find out FDA-approved medications for multiple myeloma. Multiple myeloma is a type of blood cancer that affects plasma cells, ...
Merck increases its pressure on the IRA by requesting a ruling without a trial in its conflict with the US government
Merck is intensifying its fight against the drug price negotiation provisions in the Inflation Reduction Act (IRA) by requesting a ...
Despite a lack of essential cancer medications, the FDA approves additional chemotherapy imports from China’s Qilu Pharmaceutical
The ongoing shortage of crucial chemotherapy drugs in the United States has led the FDA to import a supply from ...
After an FDA inspection at an Indian manufacturing facility, Lupin turns off the light
Source – Lupin Lupin, a major generics company, has received a relatively mild rebuke from the US Food and Drug ...
How will Medicare be affected by the cost of Leqembi from Eisai and Biogen? Sen. Sanders is curious
Senator Bernie Sanders (I-Vt.) is increasing his pressure on the US Department of Health and Human Services (HHS) regarding the ...
