FDA

AstraZeneca, Breztri, FDA, FDA warning letter, AstraZeneca Misleading Ads

FDA Issues Warning Letter to AstraZeneca Regarding ‘Misleading’ Breztri Efficacy Claims

Anika Sharma

AstraZeneca’s promotional campaign for Breztri Aerosphere, a treatment for chronic obstructive pulmonary disease (COPD), has encountered significant regulatory turbulence, with ...

Revance, FDA, Daxxify, Cervical dystonia, FDA Approval

Revance into Therapeutic Realm with FDA Approval for Cervical Dystonia Treatment, Daxxify

SG Tylor

Revance, a prominent player in the aesthetics market, has now made a strategic move into the promising therapeutic arena. Following ...

Johnson & Johnson, Talvey, FDA, Multiple myeloma, FDA Approval, Talquetamab

Johnson & Johnson Takes Lead in Bispecific Antibody Approval for Multiple Myeloma, Leaving Pfizer in the Dust

SG Tylor

The FDA has granted accelerated approval to talquetamab-tgvs, branded as Talvey, for treating relapsed or refractory multiple myeloma in adults ...

FDA Grants Orphan Status to ABM-1310 for Glioblastoma

ABM-1310 receives Orphan Drug Designation from the FDA for Glioblastoma

SG Tylor

Source – ABM Therapeutics ABM Therapeutics has received orphan drug designation from the FDA for ABM-1310, a novel small molecule ...

How Ervebo Can Protect Children Against Ebola Virus Disease

Merck’s Ervebo has received US FDA approval for use in children 12 months of age and older

SG Tylor

Source – Merck Merck announced that the US Food and Drug Administration (FDA) has granted expanded approval for Ervebo. The ...

Jemperli Approved for First-Line Endometrial Cancer Therapy

Endometrial Cancer Patients Get New Option with Jemperli

SG Tylor

Source – GSK GSK has secured approval from the US for Jemperli, in combination with chemotherapy, as a first-line treatment ...

Lonsurf Gets FDA Approval for Colorectal Cancer

Lonsurf gets a boost from FDA for colorectal cancer, challenging rivals Takeda and Hutchmed

SG Tylor

Source – Taiho Oncology  Eight years after initially gaining FDA approval for the treatment of heavily pretreated colorectal cancer, Taiho ...

IVS-3001 Gets Fast Track Status for RCC Treatment

IVS-3001 been given Fast Track Designation by the FDA for RCC

SG Tylor

The FDA has granted fast track designation (FTD) to IVS-3001, an innovative chimeric antigen receptor (CAR) T-cell therapy, intended for ...

Citius’ IL-2 Therapy Fails to Win FDA Approval for Lymphoma

FDA rejects Citius’ resurrected IL-2 lymphoma treatment

SG Tylor

Source – Citius Pharmaceuticals  The FDA has declined Citius Pharmaceuticals’ request to market Lymphir, an updated version of a lymphoma ...

Tirzepatide: Eli Lilly’s Breakthrough Drug for Obesity

Eli Lilly’s Tirzepatide Succeeds in 2 More Late-Stage Obesity Trials Ahead of FDA Decision

SG Tylor

Source – Eli Lilly Eli Lilly continues to gather strong evidence supporting the effectiveness of tirzepatide, its dual GIP/GLP-1 agonist, ...

Revlimid Revenue to Fall by $1B, Bristol Myers Says

Bristol Myers lowers the company’s 2023 revenue forecast for Revlimid by $1 billion

SG Tylor

Bristol Myers Squibb (BMS) had a promising long-term outlook after securing FDA approvals for three drugs with peak sales potential ...

FDA Approves Balfaxar, a Life-Saving Warfarin Reversal Drug

Balfaxar, a warfarin reversal medication from Octapharma, receives FDA approval

SG Tylor

Source – Octapharma More than 2.4 million individuals in the United States rely on warfarin, a blood thinner, to prevent ...

FDA Approves Xdemvy: Breakthrough for Eyelid Disease

Tarsus’ Xdemvy is approved by the FDA as the first therapy for common eyelid illness

SG Tylor

Source – Tarsus Pharmaceuticals Tarsus Pharmaceuticals has achieved a groundbreaking milestone with the FDA approval of Xdemvy, the first-ever treatment ...

Exelixis and Teva Settle Cabometyx Patent Dispute, Allow Generic in 2031

Cabometyx patent battle is resolved by Exelixis and Teva with a 2031 generic license

SG Tylor

Source – Exelixis Exelixis, the company behind the successful cancer drug Cabometyx, has been actively defending its intellectual property. In ...

Centaur Pharma in Trouble: FDA Finds Serious Violations

FDA issues a warning notice to Centaur Pharmaceuticals detailing quality and sanitation violations

SG Tylor

Centaur Pharmaceuticals, a company based in India, recently faced scrutiny from the FDA due to issues discovered during an inspection ...

FDA Approves Emergent’s Cyfendus, an Anthrax Vaccine with 4 Years of Supply History

FDA Grants Approval to Emergent’s Anthrax Vaccine Cyfendus After 4 Years of Supplying the Shot

SG Tylor

Source – Emergent BioSolutons Emergent BioSolutions has been delivering its AV7909 anthrax vaccine to the Department of Health and Human ...

Selinexor: A Breakthrough Drug for Myelofibrosis Patients

Selinexor Receives Fast Track Designation from FDA for Myelofibrosis Treatment

SG Tylor

Source – Karyopharm Therapeutics The FDA has granted fast track designation to selinexor (Xpovio) for the treatment of patients with ...

Rivoceranib and Camrelizumab: A New Combination for Liver Cancer

Rivoceranib Plus Camrelizumab NDA for Unresectable HCC is Accepted by the FDA

SG Tylor

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

FDA Approves IND for Selected Advanced Solid Tumors Using ADRX-0706

SG Tylor

Source – Adcentrx Therapeutics The FDA has granted clearance to Adventrx Therapeutics’ IND application for ADRX-0706, a promising treatment for ...

Catalent’s Indiana Facility Faces FDA Observations After Eylea Rejection

Catalent’s Indiana Facility Faces FDA Observations After Eylea Rejection

SG Tylor

Following an unexpected rejection from the FDA for Regeneron’s high-dose Eylea, the FDA disclosed issues related to cleaning and procedures ...

Apellis’ Syfovre Linked to Eye Inflammation in Geographic Atrophy Patients

Apellis’ Syfovre Linked to Eye Inflammation in Geographic Atrophy Patients

SG Tylor

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

FDA has approved Beyfortus as a treatment for RSV illness in newborns

SG Tylor

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

FDA Issues ODD for Gallium Maltolate for Pediatric GBM

SG Tylor

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

FDA states that LN-145 in NSCLC is likely to receive accelerated approval

SG Tylor

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) ...

Arrival of OTC birth control in the US

The Arrival of OTC birth control in the US

SG Tylor

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

FDA-Approved Medications for Multiple Myeloma: What You Need to Know

SG Tylor

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 increases its pressure on the IRA by requesting a ruling without a trial in its conflict with the US government

SG Tylor

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

Despite a lack of essential cancer medications, the FDA approves additional chemotherapy imports from China’s Qilu Pharmaceutical

SG Tylor

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

After an FDA inspection at an Indian manufacturing facility, Lupin turns off the light

SG Tylor

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

How will Medicare be affected by the cost of Leqembi from Eisai and Biogen? Sen. Sanders is curious

SG Tylor

Senator Bernie Sanders (I-Vt.) is increasing his pressure on the US Department of Health and Human Services (HHS) regarding the ...