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Arcutis and Huadong announce strategic collaboration and licensing agreement for topical roflumilast in Greater China and Southeast Asia

Written by | 20 Aug 2023

Arcutis Biotherapeutics, Inc. and Hangzhou Zhongmei Huadong Pharmaceutical Co, a wholly owned subsidiary of Huadong Medicine Co., Ltd. (SZ.000963), announced that the companies have entered into a strategic… read more.

Elrexfio receives FDA accelerated approval for relapsed or refractory multiple myeloma – Pfizer

Written by | 19 Aug 2023

Pfizer Inc. announced the FDA has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received… read more.

FDA approval for the POLARx cryoablation system for the treatment of patients with paroxysmal atrial fibrillation – Boston Scientific

Written by | 18 Aug 2023

Boston Scientific Corporation announced it has received FDA approval for the POLARx Cryoablation System.The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation… read more.

FDA approves Akeega, the first-and-only dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer – Janssen

Written by | 17 Aug 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Akeega (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor… read more.

Bristol Myers Squibb launches Clear Understanding Campaign to reveal the plain truth about living with moderate to severe plaque psoriasis

Written by | 16 Aug 2023

Bristol Myers Squibb has launched Clear Understanding, a campaign featuring patients living with moderate to severe plaque psoriasis who are sharing what it’s really like for them to… read more.

FDA approves Talvey a first-in-class bispecific therapy for the treatment of patients with heavily pretreated multiple myeloma – Janssen Pharma

Written by | 15 Aug 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has granted accelerated approval of Talvey (talquetamab-tgvs), a first-in-class bispecific antibody for the treatment of adult… read more.

US CDC recommends Beyfortus for prevention of respiratory syncytial virus – Sanofi /AstraZeneca

Written by | 14 Aug 2023

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously 10 to 0 to recommend routine use of Sanofi and AstraZeneca’s… read more.

European Commission adopts decision endorsing CHMP recommendation to revoke the conditional marketing authorization for Adakveo – Novartis

Written by | 13 Aug 2023

On 26 May 2023, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended revoking the conditional marketing authorization (MA) for crizanlizumab. On 3… read more.

FDA approves Izervay for geographic atrophy – Astellas/Iveric

Written by | 12 Aug 2023

Astellas Pharma Inc announced the FDA approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4,… read more.

FDA approves expanded indication for Ervebo in Zaire ebolavirus – Merck Inc

Written by | 11 Aug 2023

Merck Inc announced that the FDA has approved an expanded indication for Ervebo, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals… read more.

Abbott initiates US market withdrawal of Trifecta family of heart valves

Written by | 10 Aug 2023

Abbott is initiating a US market withdrawal for the Trifecta family of valves and will be removing the limited remaining inventory from the field. On February 27, 2023,… read more.

FDA approves Zurzuvae, the first and only oral treatment for postpartum depression, and issues a complete response letter for major depressive disorder – Sage Therapeutics + Biogen

Written by | 9 Aug 2023

Sage Therapeutics, Inc .and Biogen Inc. announced the FDA approved Zurzuvae (zuranolone) 50 mg for adults with postpartum depression (PPD). Zurzuvae is the first and only oral, once-daily,… read more.

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