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FDA Approves Empaveli (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)

WALTHAM, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Foo

FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain

SAN DIEGO, May 13, 2021 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatme

Novavax and Takeda Finalize License Agreement for Novavax’ COVID-19 Vaccine Candidate in Japan; Takeda Initiates Phase 1/2 Trial in Japan

GAITHERSBURG, Md., February 25, 2021 -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its colla

Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

The evaluation is part of the Phase 1/2/3 trial and will study a third dose of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, at 30 µg that will be given to Phase 1 participants to evaluate the safet

Independent Data Monitoring Committee Finds Clear Efficacy for REGEN-COV™ (casirivimab with imdevimab) in Phase 3 COVID-19 Outpatient Outcomes Trial

TARRYTOWN, N.Y., Feb. 25, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced changes to the Phase 3 trial assessing investigational REGEN-COV™ (casirivimab with imdevi

GSK Announces Results Evaluating its Investigational Monoclonal Antibody Otilimab for the Treatment of Hospitalised Adult Patients with COVID-19

25 February 2021 -- London UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced results from the phase 2 proof of concept OSCAR (Otilimab in Severe COVID-19 Related Disease) study with otilimab, an

Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission For Libervant™ (Diazepam) Buccal Film Following FDA Feedback

WARREN, N.J., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address pat

Daiichi Sankyo and LYSA-LYSARC-CALYM Enter Research Collaboration for Valemetostat in Patients with Relapsed/Refractory B-Cell Lymphoma

TOKYO & BASKING RIDGE, N.J. & MUNICH & LYON, France -- (BUSINESS WIRE) February 24, 2021 --Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and LYSA-LYSARC-CALYM today announced

Moderna Announces it has Shipped Variant-Specific Vaccine Candidate, mRNA-1273.351, to NIH for Clinical Study

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 24, 2021 -- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announces that it has completed man

FDA Approves Kloxxado (naloxone hydrochloride) Nasal Spray for Emergency Treatment of Opioid Overdose

LONDON, April 30, 2021 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the

INOVIO Announces First Subject Dosed in Phase 1B Clinical Trial for its DNA Vaccine Against Lassa Fever, INO-4500, in West Africa

PLYMOUTH MEETING, Pa., Feb. 23, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infect

FDA Accepts for Priority Review Pfizer’s Application for TicoVac™ (Tick-borne Encephalitis Vaccine)

February 23, 2021 - NEW YORK--(BUSINESS WIRE) -- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Ap