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.

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 ...

The first respiratory syncytial virus (RSV) vaccine for elderly people, GSK's Arexvy, received approval from the Medicines and Healthcare Products Regulatory Agency

The first respiratory syncytial virus (RSV) vaccine for elderly people, GSK’s Arexvy, received approval from the Medicines and Healthcare Products Regulatory Agency

SG Tylor

Source – GSK GSK has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted ...

Better receives FDA approval for its primary DTx medication

Better receives FDA approval for its primary DTx medication

SG Tylor

Source –Better Therapeutics On 10 July, Digital health company Better Therapeutics received FDA approval for its lead digital therapeutic (DTx), ...

Roche's Columvi (glofitamab) for patients with R_R diffuse large B-cell lymphoma has received approval from the European Commission

Roche’s Columvi (glofitamab) for patients with R/R diffuse large B-cell lymphoma has received approval from the European Commission

SG Tylor

Source – Roche On 11 July 2023 Roche announced that the European Commission (EC) has given conditional approval for Columvi ...

Novavax's Covid vaccine receives a unanimous EU approval

Novavax’s Covid vaccine receives a unanimous EU approval

SG Tylor

Source –  Novavax Novavax received full Marketing Authorization (MA) from the European Commission for its COVID-19 vaccine, Nuvaxovid (NVX-CoV2373). This ...

European Commission Grants Approval for ORKAMBI to Treat Cystic Fibrosis in Children. Pharmtales - Latest Pharma News and Insights

European Commission Grants Approval for ORKAMBI to Treat Cystic Fibrosis in Children Aged 1 to <2 Years

SG Tylor

Source –  Vertex Pharmaceuticals On July 5, 2023, Vertex Pharmaceuticals announced that the European Commission has granted approval for the ...

Epcoritamab Receives FDA Approval – A Game-Changer in Cancer Treatment

FDA Grants Approval to Epcoritamab– Redefining the Future of DLBCL

SG Tylor

In the world of cancer treatment, groundbreaking advancements are constantly being made, offering new hope for patients and their loved ...

Eisai and Biogen Embark on Full Launch of Leqembi Following Alzheimer's Approval - Lates USA Pharma News By Pharmtales

Eisai and Biogen Embark on Full Launch of Leqembi Following Alzheimer’s Approval

SG Tylor

Source – Eisai On July 6, 2023, Eisai and Biogen received full approval from the FDA for their Alzheimer’s disease ...

Roche withdraws Gavreto approval, citing study impracticality

Roche withdraws Gavreto approval, citing study impracticality

SG Tylor

Roche’s cancer drug Gavreto was withdrawn for the treatment of advanced RET-mutant medullary thyroid cancer, following discussions with the FDA. ...

Cyclophosphamide Injection's NDA for a Number of Cancers Receives FDA Approval

FDA Approves Cyclophosphamide Injection NDA for Multiple Cancers

SG Tylor

Source – Nevakar Injectables On July 3, 2023 the FDA has approved a new drug application (NDA) for 200-mg/mL vials ...

First cell treatment for type I diabetes is approved by the FDA | News By Pharmtales

First cell treatment for type I diabetes is approved by the FDA

SG Tylor

Source – FDA On June 29, 2023, CellTrans achieved a significant milestone by securing the first-ever FDA approval for a ...

BMS' Sotyktu is approved for psoriasis usage by the NHS | Pharmtales

BMS’ Sotyktu is approved for psoriasis usage by the NHS

SG Tylor

Source: Bristol-Myers Squibb Just weeks after receiving approval in the UK, Bristol-Myers Squibb’s novel oral therapy for psoriasis, SotyKtu, has ...

BioMarin's Roctavian_ FDA Approves Hemophilia A Gene Therapy with Positive Reception from Physician | pharmtales

BioMarin’s Roctavian: FDA Approves Hemophilia A Gene Therapy with Positive Reception from Physician

SG Tylor

Source – BioMarin BioMarin’s Roctavian, a gene therapy for severe hemophilia A, has received FDA approval after initial rejection in ...

Shingrix Granted Approval by Japan's Ministry of Health Labour and Welfare for Shingles Prevention in At-Risk Individuals 18 Years and Older - Pharmtales - Latest Pharma News & Analysis

Shingrix Granted Approval by Japan’s Ministry of Health Labour and Welfare for Shingles Prevention in At-Risk Individuals 18 Years and Older

SG Tylor

Source – GSK On 26  June 2023, GSK announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has ...

Reata Pharmaceuticals Begins Launching Its First Commercial Product Skyclarys with Approved Supplement - Pharmtales - Latest Pharma News & Analysis

Reata Pharmaceuticals Begins Launching Its First Commercial Product Skyclarys with Approved Supplement

SG Tylor

Source – Reata Pharmaceuticals After receiving approval in the spring, Reata Pharmaceuticals has been eagerly awaiting the launch of its ...

Pediatric Growth Hormone Deficiency Long-Acting Once-Weekly Treatment NGENLA by Pfizer Receives FDA Approval Pharmtales - Latest Pharma News & Analysis - Pharmtales - Latest Pharma News & Analysis

Pediatric Growth Hormone Deficiency Long-Acting Once-Weekly Treatment NGENLA by Pfizer Receives FDA Approval

SG Tylor

Source – Pfizer On 29 June 2023, Pfizer and OPKO Health jointly announced that the US Food and Drug Administration ...

UCB has achieved a long-awaited victory as the FDA grants approval for the myasthenia gravis drug Rystiggo _ Pharmtales - Latest Pharma News & Insights

UCB has achieved a long-awaited victory as the FDA grants approval for the myasthenia gravis drug Rystiggo

SG Tylor

Source – UCB On 27 June 2023, UCB faced regulatory challenges in the United States for the second consecutive year, ...

Xigduo XR Receives Approval in China for the Treatment of Type II Diabetes in Adults

Xigduo XR Receives Approval in China for the Treatment of Type II Diabetes in Adults

SG Tylor

Source – AstraZeneca  On June 27, 2023, AstraZeneca’s Xigduo XR, a once-daily fixed-dose combination of dapagliflozin and metformin hydrochloride extended-release, ...

FDA Grants Approval to Pfizer's LITFULO (Ritlecitinib) for Severe Alopecia Areata

FDA Grants Approval to Pfizer’s LITFULO (Ritlecitinib) for Severe Alopecia Areata in Adults and Adolescents

SG Tylor

Source: Pfizer Pfizer announced on June 23, 2023, that the U.S. Food and Drug Administration (FDA) has granted approval to ...

Talazoparib Plus Enzalutamide for HRR Gene-Altered mCRPC Receives FDA Approval

Talazoparib Plus Enzalutamide for HRR Gene-Altered mCRPC Receives FDA Approval

SG Tylor

Source – FDA On June 20, 2023, the combination of talazoparib (Talzenna) and enzalutamide (Xtandi) has been approved by the ...

Argenx receives FDA approval for the first gMG subcutaneous treatment

Argenx receives FDA approval for the first gMG subcutaneous treatment

SG Tylor

Source – Argenx  Argenx has claimed an FDA clearance that might increase its market share in the increasingly competitive market ...

The US FDA has approved the use of Jardiance (empagliflozin) to treat type II diabetes in children and adolescents aged 10 and older

The US FDA has approved the use of Jardiance (empagliflozin) to treat type II diabetes in children and adolescents aged 10 and older

SG Tylor

Source – Eli Lilly On June 21, 2023, Boehringer Ingelheim and Eli Lilly and Company announced that the US Food ...

Glofitamab-gxbm receives FDA approval for relapsing or resistant DLBCL

Glofitamab-gxbm receives FDA approval for relapsing or resistant DLBCL

SG Tylor

Source – Roche Columvi (Glofitamab-gxbm) has been given expedited clearance by the FDA for the treatment of adult patients with ...

Companion Diagnostic for Encorafenib + Cetuximab in BRAF V600E alteration in mCRC Receives FDA Approval

Companion Diagnostic for Encorafenib + Cetuximab in BRAF V600E alteration in mCRC Receives FDA Approval

SG Tylor

Source – Foundation Medicine In order to identify patients with metastatic colorectal cancer (mCRC) who could be candidates to receive ...

FDA authorizes the first medication for functional constipation in children

FDA authorizes the first medication for functional constipation in children

SG Tylor

Source- FDA Pediatric patients aged 6 to 17 may use Linzess (linaclotide) pills to treat functional constipation. The first therapy ...

Futura receives FDA approval for OTC treatment for erectile dysfunction

Futura receives FDA approval for OTC treatment for erectile dysfunction

SG Tylor

Source- Futura Medical The first business in the US to provide a topical erectile dysfunction medication to the market without ...

For the treatment of people with refractory generalized myasthenia gravis, Soliris has received approval in China

For the treatment of people with refractory generalized myasthenia gravis, Soliris has received approval in China

SG Tylor

Source- Astrazeneca For the treatment of adult patients with refractory generalized myasthenia gravis (gMG) and anti-acetylcholine receptor (AChR) antibody positivity, ...

FDA Advisory Committee Unanimously Recommends Nirsevimab for Preventing RSV Lower Respiratory Tract Disease in Infants

FDA Advisory Committee Unanimously Recommends Nirsevimab for Preventing RSV Lower Respiratory Tract Disease in Infants

SG Tylor

Source: AstraZeneca The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) has voted unanimously, with a 21 to 0 decision, affirming the ...

European Commission Approves COSENTYX as First and Only IL-17A Inhibitor for Hidradenitis Suppurativa

European Commission Approves COSENTYX as First and Only IL-17A Inhibitor for Hidradenitis Suppurativa

SG Tylor

Source: Novartis On June 1, 2023, Novartis announced that the European Commission (EC) has granted approval for the use of ...

FDA Advisory Committee Vote Validates LEQEMBI Alzheimer's Treatment

FDA Advisory Committee Vote Validates LEQEMBI Alzheimer’s Treatment

SG Tylor

Source: Eisai On June 9, 2023, the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) of the US Food ...