FDA Grants Fast Track Designation to Sanofi’s Combination Vaccines for Influenza and COVID-19 in Older Adults

The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infec...

December 13, 2024 | Friday | News
COFEPRIS Approves LEQEMBI® (Lecanemab) for Early Alzheimer's Disease in Mexico

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

December 09, 2024 | Monday | News
Nxera Pharma Launches Phase 3 Trial of QUVIVIQ™ (Daridorexant) in South Korea to Address Insomnia Epidemic

Daridorexant is a dual orexin receptor antagonist being developed by Nxera for the treatment of adult patients with insomnia QUVIVIQ™ (daridorex...

December 05, 2024 | Thursday | News
AstraZeneca’s Truqap Combination Shows Significant Benefit in PTEN-Deficient Prostate Cancer in CAPItello-281 Phase III Trial

Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca’s Truqap (capivasertib) in combination with ...

November 26, 2024 | Tuesday | News
Zevra Therapeutics Launches MIPLYFFA™, the First FDA-Approved Treatment for Niemann-Pick Disease Type C

MIPLYFFA, the first FDA-approved treatment for Niemann-Pick disease type C, is available at Zevra’s specialty pharmacy for dispense AmplifyAssist&...

November 22, 2024 | Friday | News
Gilead Sciences to Present Groundbreaking HIV Research at HIV Glasgow 2024, Highlighting Advances in Treatment and Prevention

Gilead Sciences, Inc. (Nasdaq: GILD) announced the upcoming presentation of HIV research findings at the International Congress on Drug Therapy in HIV Infe...

November 08, 2024 | Friday | News
Acadia Pharmaceuticals to Sell Rare Pediatric Disease Priority Review Voucher for $150 Million

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that it entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority...

November 06, 2024 | Wednesday | News
Ionis Pharmaceuticals Announces FDA Acceptance of NDA for Donidalorsen, a Potential Prophylactic Treatment for Hereditary Angioedema

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New ...

November 05, 2024 | Tuesday | News
Kind Pharmaceutical Secures FDA Orphan Drug Designation for Sickle Cell Disease Treatment AND017

Kind Pharmaceutical ("Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC"), a clinical-stage biopharmaceutical company focused on developing...

October 28, 2024 | Monday | News
Taiwan’s Bora Pharmaceuticals Expands Rare Disease Portfolio with Acquisition of U.S.-Based Pyros Pharmaceuticals

Bora Pharmaceuticals Co., Ltd. ("Bora" or "the Company", TWSE: 6472),  announced that its Board of Directors has approved the acquisition of US-based ...

October 28, 2024 | Monday | News
GSK Announces Promising Data for Arexvy Vaccine in Younger Adults at Risk for RSV

GSK plc (LSE/NYSE: GSK) announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at inc...

October 25, 2024 | Friday | News
European Commission Approves KEYTRUDA for New Indications in Gynecologic Cancers

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved two new indications for K...

October 25, 2024 | Friday | News
Sangamo Therapeutics Secures FDA Pathway for Accelerated Approval of Gene Therapy for Fabry Disease

Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, announced the outcome of a recent successful interaction with the U.S.&nbs...

October 23, 2024 | Wednesday | News
Antengene Secures South Korean Approval for XPOVIO® in Combination Therapy for Multiple Myeloma

SHANGHAI and HONG KONG, Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmac...

October 18, 2024 | Friday | News

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