Aquestive Therapeutics’ Libervan Buccal Film Receives the US FDA’s Approval to Treat Seizure Activity

Shots: Aquestive’s Libervant buccal film (oral, 5mg, 7.5mg, 10mg, 12.5mg & 15mg) received the US FDA’s approval as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures), distinct from the usual pattern in epilepsy patients (2-5yrs.) The company further provided an update on Anaphylm (epinephrine) sublingual film,…

ByDipanshu DixitApril 29, 2024

NEWS

X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome

Shots: The US FDA has approved Xolremdi (mavorixafor) capsules for treating WHIM syndrome patients (12yrs. & above) and granted a Rare Pediatric Disease Priority Review Voucher to the company The approval was supported by the P-III (4WHIM) study assessing the safety & efficacy of Xolremdi vs PBO to treat WHIM syndrome patients (n=31, 12yrs. &…

ByDipanshu DixitApril 29, 2024

NEWS

Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B

Shots: US FDA granted approval to Pfizer’s Beqvez, based on BENEGENE-2 (P-III) study (n=45) to treat of Haemophilia B adult patient using factor IX (FIX) prophylaxis therapy, with life-threatening hemorrhage, spontaneous bleeding episodes, no FDA-approved test detected neutralizing antibodies to AAVRh74var capsid; met 1EP of non-inferiority in the ABR of total bleeds Based on durability…

ByDipanshu DixitApril 26, 2024

NEWS

Bausch + Lomb’s Lumify Receives the US FDA’s Approval to Treat Ocular Redness

Shots: Bausch + Lomb has received the US FDA’s approval for Lumify Preservative Free eye drops to treat ocular redness due to minor eye irritations The studies demonstrated low incidence of side effects such as rebound redness and loss of efficacy over time with Lumify Preservative Free eye drops. The company plans its availability in…

ByDipanshu DixitApril 26, 2024

NEWS

The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)

Shots: The US FDA has granted accelerated approval to Ojemda for treating r/r pLGG patients (≥6mos.) with BRAF fusion/rearrangement or BRAF V600 mutation. It further obtained FDA’s rare pediatric disease priority review voucher The approval was based on the P-II (FIREFLY-1) study assessing the efficacy (arm 1, n=77) & safety (arm 2, n=60) of Ojemda.…

ByDipanshu DixitApril 23, 2024

NEWS

ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: ImmunityBio’s Anktiva + Bacillus Calmette-Guérin (BCG) has received the US FDA’s approval to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with/without papillary tumors. The US availability is anticipated by mid-May 2024 The approval & BTD was based on the study of 77 evaluable patients depicting a CR rate…

ByDipanshu DixitApril 22, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in March 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2024 The US FDA approved a total of 14 drugs including 12 new molecular entities and 2 biologics leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was BeiGene’s Tevimbra for treating Advanced…

ByDipanshu DixitApril 15, 2024

VIEWPOINTS

Fund Secured: MediWounds’ CEO Ofer Gonen in Conversation with PharmaShots

Shots: Ofer Gonen, CEO at MediWound, in conversation with PharmaShots, sheds light on recent funding from the US Department of Defence to further develop NexoBrid for the US Army NexoBrid an FDA-approved enzymatic therapy to treat severe burns is jointly developed by Vericel and received US FDA approval in Dec’22 MediWound secured an additional $6.7M…

BySaurabh ChaubeyApril 4, 2024

NEWS

Basilea’s Zevtera Receives the US FDA’s Approval for Staphylococcus aureus Bloodstream Infections

Shots: The US FDA has approved Zevtera to treat adult patients with SAB infections such as right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) as well as community-acquired bacterial pneumonia (CABP) in adult & pediatric patients (3mos. to <18yrs.) The NDA was based on efficacy & safety results from P-III trials incl.…

ByDipanshu DixitApril 3, 2024

INSIGHTS+

New Drug Designations – February 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, and EC. This month’s report includes designations allotted to 13 small molecules, 20 biologics, and 2 devices SN Bioscience’s SNB-101 received ODD from the US FDA for the treatment of pancreatic cancer based on preclinical results. It…

BySenior EditorMarch 28, 2024

Aquestive Therapeutics’ Libervan Buccal Film Receives the US FDA’s Approval to Treat Seizure Activity

X4 Pharmaceuticals’ Xolremdi Receives the US FDA’s Approval for the Treatment of WHIM Syndrome

Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B

Bausch + Lomb’s Lumify Receives the US FDA’s Approval to Treat Ocular Redness

The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)

ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)

Insights+: The US FDA New Drug Approvals in March 2024

Fund Secured: MediWounds’ CEO Ofer Gonen in Conversation with PharmaShots

Basilea’s Zevtera Receives the US FDA’s Approval for Staphylococcus aureus Bloodstream Infections

New Drug Designations – February 2024

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