This week PharmaShots’ news was all about the updates on Regulatory, Clinical Trials,Pharma, Pharma, Animal Health & MedTech. Check out our full report below:

The US FDA Approves Gilead’s Vemlidy 25mg Tablets for the Treatment of Chronic Hepatitis B Virus (HBV) Infection in Pediatric Patients

Read More: Gilead                                                  

The US FDA Approves AstraZeneca’s Voydeya as an Add-on Therapy to Treat Extravascular Haemolysis in PNH Patients

Read More: AstraZeneca                                       

The US FDA Grants ODD to Biostar Pharma’s Utidelone Injectable to Treat Breast Cancer Brain Metastasis

Read More: Biostar Pharma                                      

Fractyl Health’s IDE for Revita Receives the US FDA Approval for Conducting Remain-1 Study to Treat Obesity

Read More: Fractyl Health                                   

HUTCHMED and Innovent Report the NMPA’s NDA Acceptance for Fruquintinib Plus Sintilimab with Priority Review to Treat Endometrial Cancer

Read More: HUTCHMED                                       

The US FDA Accepts AstraZeneca and Daiichi Sankyo’s BLA of Datopotamab Deruxtecan (Dato-DXd) to Treat Breast Cancer

Read More:  AstraZeneca and Daiichi Sankyo’s       

The EMA Accepts Rocket Pharmaceuticals’ MAA of RP-L102 for Treating Fanconi Anemia

Read More:  Rocket Pharmaceuticals                       

The EC Expands Approval of BMS’ Reblozyl as a 1L Treatment of Transfusion-Dependent Anemia Due to Myelodysplastic Syndromes

Read More: BMS                                                        

Vanda Pharmaceuticals’ Fanapt Gains the US FDA’s Approval to Treat Bipolar I Disorder

Read More: Vanda Pharmaceuticals                                                   

The US FDA Accepts UCB’s sBLA of Bimzelx (bimekizumab-bkzx) for the Treatment of Hidradenitis Suppurativa

Read More: UCB                                                                        

Incyte and China Medical System Collaborate on Povorcitinib for Autoimmune and Inflammatory Dermatologic Indications

Read More: Incyte and China Medical System        

 Ipsen and Sutro Biopharma Join Forces on STRO-003 for Treating Solid Tumors

Read More: Ipsen and Sutro Biopharma                

MaxCyte Partners with Be Biopharma to Develop Engineered B Cell Medicines (BCMs)

Read More: MaxCyte                                               

Caris Life Sciences and Merck KGaA Join Forces to Discover and Develop ADCs for Cancer Treatment

Read More: Caris Life sciences and Merck               

MiNA Therapeutics and Nippon Shinyaku Partner on RNAa Therapeutics for Rare Neurodegenerative Diseases

Read More: MiNA Therapeutics and Nippon Shinyaku       

For an Aggregate of $1.8B, Genmab to Acquire ProfoundBio for Enhancing its Oncology Portfolio 

Read More: Genmab                                                    

ARCA Biopharma Merges with Oruka Therapeutics to Develop Biologics for Chronic Skin Diseases

Read More: ARCA & Oruka                                    

For an Aggregate of ~$13.1B, Johnson & Johnson to Acquire Shockwave Medical

Read More: Johnson & Johnson & Shockwave Medical                 

PassPort Technologies Reveals P-I Study Results of Zolmitriptan Transdermal Microporation System to Treat Acute Migraine

Read More: PassPort Technologies                      

The US FDA Clears Abbott’s Whole Blood Rapid Test for Evaluating Patients with Suspected Concussion 

Read More:  Abbott                                                     

The US FDA Approves Abbott’s Triclip Transcatheter Edge-To-Edge Repair System to Treat Tricuspid Regurgitation

Read More: Abbott                  

The US FDA Grants 510(k) Clearance to AngioDynamics’ AlphaVac F18⁸⁵ System for the Treatment of Pulmonary Embolism

Read More:Angiodynamics                  

 BMS Reveals the P-III (YELLOWSTONE) Trial Results of Zeposia for Treating Moderate to Severe Active Crohn’s Disease

Read More: BMS                                                      

EnteroBiotix Reports the Initiation of P-II Study Evaluating EBX-102-02 to Treat Irritable Bowel Syndrome (IBS)

Read More: EnteroBiotix                                                   

Merck and Daiichi Sankyo Dose First Patient with Raludotatug Deruxtecan in P-II/III (REJOICE-Ovarian01) Study to Treat Ovarian Cancer

Read More: Merck & Daiichi Sankyo                                                  

SpliSense Receives the US FDA’s Clearance for SPL84 P-II Clinical Evaluation to Treat Cystic Fibrosis

Read More: SpliSense                                                        

Neurocrine Biosciences Reports First Patient Dosing with NBI-1070770 Under the P-II Study to Treat Major Depressive Disorder

Read More: Neurocrine Bioscience                                                      

Merck Reports the Commencement of MK-1084’s P-III Study in Combination with Keytruda for Treating Metastatic Non-Small Cell Lung Cancer

Read More: Merck                                                                              

AstraZeneca Reports the P-III Study Results of Imfinzi for the Treatment of Small Cell Lung Cancer

Read More: AstraZeneca                                                                    

Teva Pharmaceuticals Partners with mAbxience to Develop Biosimilar Candidates for Treating Oncology Indications

Read More: Teva Pharmaceuticals                                                         

Related Post:- PharmaShots Weekly Snapshots (March 26 – March 29, 2024)