Biopharma

Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem trihydrate,vaborbactam, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0530/2023

Opinion/decision on a Paediatric investigation plan (PI...

Feb 13, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem tr...

New product information wording – Extracts from PRAC re...

Feb 13, 2025 0

New product information wording – Extracts from PRAC recommendations on signals ...

Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 13, 2025 0

Human medicines European public assessment report (EPAR): Drovelis, estetrol,dro...

VC Longwood Fund unveils neuro biotech with $93M, assets licensed from Roche

VC Longwood Fund unveils neuro biotech with $93M, asset...

Feb 13, 2025 0

Newleos Therapeutics is making its debut with $93.5 million aimed at developing ...

$U.S. FDA Approves Pfizer’s Adcetris Combination Regimen for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma$

U.S. FDA Approves Pfizer’s Adcetris Combination Regimen...

Feb 13, 2025 0

NEW YORK--(BUSINESS WIRE) February 12, 2025 -- Pfizer Inc. (NYSE: PFE) announced...

Aardvark prices $94M IPO to fund Prader-Willi, obesity drug work

Aardvark prices $94M IPO to fund Prader-Willi, obesity ...

Feb 13, 2025 0

Proceeds will support testing of drugs designed to suppress hunger in people wit...

FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)

FDA Approves Genentech’s Evrysdi Tablet as First and On...

Feb 13, 2025 0

South San Francisco, CA -- February 12, 2025 -- Genentech, a member of the Roche...

Palvella Therapeutics to Expand Phase 3 SELVA Clinical Trial of Qtorin 3.9% Rapamycin Anhydrous Gel (Qtorin rapamycin) for the Treatment of Microcystic Lymphatic Malformations to Include the Younger Pediatric Population, Children 3 to 5 Years Old

Palvella Therapeutics to Expand Phase 3 SELVA Clinical ...

Feb 13, 2025 0

WAYNE, Pa., Feb. 10, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeuti...

Spinogenix Completes Phase 2 Study of SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism, Showing Strong Efficacy Signal in Measures of Abnormal Brain Activity

Spinogenix Completes Phase 2 Study of SPG601 for Treatm...

Feb 13, 2025 0

LOS ANGELES, Calif., February 11, 2025 — Spinogenix, Inc., a clinical-stage biop...

Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma

Tempest Granted Fast Track Designation from the U.S. Fo...

Feb 13, 2025 0

BRISBANE, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (...

Ex-DeepMind scientist launches AI drug discovery venture

Ex-DeepMind scientist launches AI drug discovery venture

Feb 13, 2025 0

Simon Kohl aims to capitalise on his experience with Nobel Prize-winning AlphaFo...

STAT+: With $40 million, former DeepMind employees launch startup ‘laser-focused’ on AI protein design

STAT+: With $40 million, former DeepMind employees laun...

Feb 13, 2025 0

Former DeepMind employees raise $40 million to launch London-based startup 'lase...

Ex DeepMind scientist launches AI drug discovery venture

Ex DeepMind scientist launches AI drug discovery venture

Feb 13, 2025 0

Simon Kohl aims to capitalise on his experience with Nobel Prize-winning AlphaFo...

Medicare removes sexual orientation, gender identity questions from enrollment forms

Medicare removes sexual orientation, gender identity qu...

Feb 12, 2025 0

President Trump ordered federal agencies to scrub references to “gender ideology...

'We cannot stay silent': Novo Nordisk flags dangers of compounded GLP-1s following Hims & Hers Super Bowl ad

'We cannot stay silent': Novo Nordisk flags dangers of ...

Feb 12, 2025 0

Telehealth company Hims & Hers stirred up controversy by debuting a 2025 Super B...

STAT+: As Trump pauses enforcement of an anti-bribery law, will pharma engage in bad behavior?

STAT+: As Trump pauses enforcement of an anti-bribery l...

Feb 12, 2025 0

The Trump administration's decision to pause enforcement of an anti-bribery law ...

‘We cannot stay silent’: Novo Nordisk flags dangers of compounded GLP-1s following Hims & Hers Super Bowl ad

‘We cannot stay silent’: Novo Nordisk flags dangers of ...

Feb 12, 2025 0

Telehealth company Hims & Hers stirred up controversy by debuting a 2025 Super B...

Pfizer's blockbuster ADC Adcetris nabs FDA approval to treat large B-cell lymphoma

Pfizer's blockbuster ADC Adcetris nabs FDA approval to ...

Feb 12, 2025 0

More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Ad...

Journey of Voyager's ALS gene therapy to clinic hindered by need to find alternative payload

Journey of Voyager's ALS gene therapy to clinic hindere...

Feb 12, 2025 0

Voyager Therapeutics no longer expects to take its amyotrophic lateral sclerosis...

Oligonucleotide stops gene expansion process that drives Huntington's disease: study

Oligonucleotide stops gene expansion process that drive...

Feb 12, 2025 0

Less than a month after researchers unveiled that a “ticking DNA clock” is behin...

AnaptysBio's PD-1 drug reduces rheumatoid arthritis in phase 2 trial

AnaptysBio's PD-1 drug reduces rheumatoid arthritis in ...

Feb 12, 2025 0

AnaptysBio may have ended last year on a low, but 2025 is looking up with the ne...

Roche nabs FDA nod for Evrysdi tablets, bolstering convenience edge over rivals

Roche nabs FDA nod for Evrysdi tablets, bolstering conv...

Feb 12, 2025 0

The FDA on Wednesday gave the thumbs up to a tablet formulation of Roche's Evrys...

Michigan CRO buys Exploristics for its cloud-based modeling platform

Michigan CRO buys Exploristics for its cloud-based mode...

Feb 12, 2025 0

Michigan-based clinical research organization MMS is boosting its data science p...

Oligonucleotide stops gene expansion process that drives Huntington’s disease: study

Oligonucleotide stops gene expansion process that drive...

Feb 12, 2025 0

Less than a month after researchers unveiled that a “ticking DNA clock” is behin...

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