Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma
17 juil. 2023 09h00 HE
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Elevar Therapeutics
FORT LEE, N.J., July 17, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., and a fully integrated biopharmaceutical company dedicated to elevating...
Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Erosive GERD
12 juin 2023 08h01 HE
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Phathom Pharmaceuticals
Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023Combined launch of vonoprazan for Erosive GERD and H. pylori indications planned for Q4 2023, if approved FLORHAM PARK, N.J., June...
FDA Approves Groundbreaking New Product Utilizing Berkshire Sterile Excipient Gel to Treat 'Butterfly Children'
25 mai 2023 11h10 HE
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Berkshire Sterile Manufacturing
Lee, MA, May 25, 2023 (GLOBE NEWSWIRE) -- On May 19, 2023, Krystal Biotech, a client of Berkshire Sterile Manufacturing (BSM), received FDA approval for VYJUVEK™, the first-ever topical gene therapy...
Phathom Pharmaceuticals Resubmits Erosive GERD New Drug Application to FDA
23 mai 2023 16h00 HE
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Phathom Pharmaceuticals
Anticipated FDA action date in Q4 2023; if approved, combined launch for Erosive GERD and H. pylori indications planned before year endIf approved, vonoprazan would be the first innovative acid...
Elevar Therapeutics Submits New Drug Application to FDA for Combination of Rivoceranib and Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma
17 mai 2023 07h00 HE
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Elevar Therapeutics
FORT LEE, N.J., May 17, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a wholly owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating...
Phathom Pharmaceuticals Announces Regulatory Update and Plans for 2023 Erosive Esophagitis and H. pylori Commercial Launch
04 avr. 2023 08h00 HE
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Phathom Pharmaceuticals
Favorable feedback following meeting with the U.S. Food and Drug Administration (FDA) allows for planned resubmission of erosive esophagitis new drug application (NDA) this quarterCombined commercial...
Elevar Therapeutics Announces Positive Pre-NDA Meeting for Rivoceranib Combination With Camrelizumab as Hepatocellular Carcinoma Treatment Option
11 oct. 2022 16h00 HE
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Elevar Therapeutics
SALT LAKE CITY, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who...
Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia
22 août 2022 08h00 HE
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Minerva Neurosciences, Inc
WALTHAM, Mass., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central...
ROSEN, GLOBAL INVESTOR COUNSEL, Encourages Spero Therapeutics, Inc. Investors with Losses to Secure Counsel Before Important Deadline in Securities Class Action – SPRO
05 juin 2022 17h15 HE
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The Rosen Law Firm PA
NEW YORK, June 05, 2022 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the securities of Spero...
Phathom Pharmaceuticals Announces FDA Acceptance for Filing of Vonoprazan NDA for the Treatment of Erosive Esophagitis
25 mai 2022 08h00 HE
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Phathom Pharmaceuticals
FLORHAM PARK, N.J., May 25, 2022 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for...